Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia
Official Title
Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia/Lymphoma and Non-Hodgkin Lymphoma With Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor
Acronym
Not provided
Organization
Fred Hutchinson Cancer CenterOTHER
Status Module
Record Verification Date
May 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 22, 2013Actual
Primary Completion Date
Mar 26, 2021Actual
Completion Date
Mar 26, 2021Actual
First Submitted Date
May 28, 2013
First Submission Date that Met QC Criteria
May 30, 2013
First Posted Date
May 31, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 21, 2022
Results First Submitted that Met QC Criteria
May 2, 2022
Results First Posted Date
May 25, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 2, 2022
Last Update Posted Date
May 25, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Alexandre Hirayama, Research Associate, Fred Hutchinson Cancer CenterPrincipal Investigator
Lead Sponsor
Fred Hutchinson Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This phase I/II trial studies the side effects and best dose of laboratory treated T cells to see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin lymphoma, or acute lymphoblastic leukemia that have come back or have not responded to treatment. T cells that are treated in the laboratory before being given back to the patient may make the body build an immune response to kill cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and safety of adoptive T cell therapy using ex vivo expanded autologous CD8 positive (+) and CD4+ CD19 chimeric antigen receptor (CAR)-T cells for patients with advanced CD19+ B cell malignancies.
SECONDARY OBJECTIVES:
I. To determine the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.
II. To determine if adoptively transferred T cells traffic to the bone marrow and function in vivo.
III. To determine if the adoptive transfer of CD19 CAR-T cells results in depletion of CD19+ B cells in vivo as a surrogate for functional activity.
IV. To determine if the adoptive transfer of CD19 CAR-T cells has antitumor activity in patients with measurable tumor burden prior to T cell transfer.
V. To determine if the adoptive transfer of CD19 CAR-T cells is associated with tumor lysis syndrome.
OUTLINE: This is a phase I, dose-escalation study of autologous CD19 CAR T-cells followed by a phase II study.
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells intravenously (IV) over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
DOSE DENSE EXPANSION COHORT: An additional cohort will receive a second anti-CD19-CAR lentiviral vector-transduced autologous T cell infusion without additional lymphodepleting chemotherapy 10-21 days after the first infusion if adequate CD19 CAR-T cells can be produced and appropriate criteria are met.
After completion of study treatment, patients are followed up for at least 15 years.
Conditions Module
Conditions
CD19-Positive Neoplastic Cells Present
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Chronic Lymphocytic Leukemia
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Acute Lymphoblastic Leukemia
Refractory Chronic Lymphocytic Leukemia
Refractory Diffuse Large B-Cell Lymphoma
Refractory Mantle Cell Lymphoma
Refractory Non-Hodgkin Lymphoma
Refractory Small Lymphocytic Lymphoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
204Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ALL (high tumor burden) dose level 1
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
ALL (high tumor burden) dose level 2
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
ALL (high tumor burden) dose level 3
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
ALL (low tumor burden) dose level 1
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
Biological
Given IV
ALL (high tumor burden) dose level 1
ALL (high tumor burden) dose level 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy
Death within 8 weeks of the study cell infusion thought to be definitely or probably related to CAR T cell therapy will be assessed.
Within 8 weeks of the study cell infusion
Dose Limiting Toxicities
Outcome will be reported as a count of participants that experienced a dose limiting toxicity on the study within 30 days post infusion.
30 days
Objective Response Rate of Complete Response and Partial Response
Outcome will be reported as the count of patients per arm that experienced a complete response/partial response.
Complete response (CR): CR per Lugano criteria for nodal disease and minimal residual disease (MRD)-negative CR by flow cytometry for marrow disease.
Partial response (PR): > 50% reduction of the sum of the products of the perpendicular diameters of marker lesions, no progression of any existing lesions, and no new lesions.
Up to 1 year
Overall Survival
Outcome will be reported as a count of patients who survived up to 1 year post infusion.
Up to 1 year
Progression Free Survival
Outcome will be reported as the count of patients per arm that survived and whose disease did not progress in the 1 year timeframe post infusion.
Up to 1 year
Secondary Outcomes
Measure
Description
Time Frame
Duration of Persistence of Adoptively Transferred CD19 Chimeric Antigen Receptor (CAR)-T Cells
Duration of persistence of adoptively transferred CD19 chimeric antigen receptor (CAR)-T cells. Outcome will be reported for each of the 3 cohorts on the study. Outcome data is both count of patients alive after 1 year and count of patients with CAR-T cells detected at 1 year.
Up to day 365
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
INCLUSIONS FOR SCREENING AND LEUKAPHERESIS
Patients with CD19 expressing acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL)
Ability to understand and provide informed consent
Not human immunodeficiency virus (HIV) infected
INCLUSIONS FOR CAR-T CELL THERAPY
Patients with:
CLL who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody or who were not eligible for such therapy; patients with CLL for whom ibrutinib is now standard first line therapy, must have progressed on ibrutinib; patients with fludarabine refractory disease are eligible; patients may be treated following allogeneic hematopoietic cell transplant (HCT); for the concurrent ibrutinib cohort, patients must agree to continue on or be restarted on ibrutinib and must not have had prior intolerance to ibrutinib that would prevent this; patients managed with prior dose reductions for toxicity will continue at the reduced dose for the remainder of this study
Indolent NHL or mantle cell NHL who are beyond first remission and previously treated with chemoimmunotherapy or who were not eligible for such therapy; patients who have relapsed following autologous or allogeneic HCT are eligible
Aggressive NHL such as diffuse large B-cell lymphoma (DLBCL), who have relapsed or have residual disease following treatment with curative intent; patients should have relapsed following, or not be eligible for high-dose therapy and autologous HCT; patients with chemotherapy refractory disease or marrow involvement or comorbidities precluding successful autologous HCT are eligible; patients may be treated following allogeneic HCT
Patients with CD19 expressing, relapsed or refractory ALL
Patients with one of the above diagnoses whose disease state does not qualify but who have prognostic indicators that suggest a high risk of progression of disease may be screened and undergo leukapheresis; enrollment for T cell therapy would require meeting the full disease state eligibility
Confirmation of diagnosis
Evidence of CD19 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen or high likelihood of CD19 expression based on disease histology
Karnofsky performance status >= 60%
All patients of childbearing potential must be willing to use a contraceptive method before, during, and for at least two months after the T cell infusion
Ability to understand and provide informed consent
Exclusion Criteria:
EXCLUSIONS FOR CAR-T CELL THERAPY
Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the Principal Investigator (PI)
Serum creatinine > 2.5 mg/dL
Serum glutamic oxaloacetic transaminase (SGOT) > 5 x upper limit of normal
Bilirubin > 3.0 mg/dL
Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with a forced expiratory volume in one second (FEV1) of < 50 % of predicted will be excluded
Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% will be excluded
Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35%
Uncontrolled active infection
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jordan Gauthier
Fred Hutch/University of Washington Cancer Consortium
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fred Hutch/University of Washington Cancer Consortium
Ortiz-Maldonado V, Liang EC, Huang JJ, Jeon Y, Hirayama AV, Kimble EL, Portuguese AJ, Khouderchah C, Braathen K, Torkelson A, Kirchmeier D, Shadman M, Maloney DG, Riddell SR, Turtle CJ, Gauthier J. A novel dose-dense strategy for CD19-directed CAR T-cell therapy is associated with durable responses without increased toxicity in patients with B-cell non-Hodgkin lymphoma. Haematologica. 2026 Jul 2. doi: 10.3324/haematol.2025.300321. Online ahead of print.
204 patients were enrolled on this study but only 197 met eligibility criteria and went on to be treated on study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Yes
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 1, 2021
Mar 18, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
ALL (low tumor burden) dose level 2
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
CLL dose level 1
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
CLL dose level 2
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
CLL dose level 3
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
CLL (ibrutinib) dose level 2
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
NHL dose level 1
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
NHL dose level 2
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
NHL dose level 3
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
NHL (dose dense) dose level 2
Experimental
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Biological: Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes
ALL (high tumor burden) dose level 3
ALL (low tumor burden) dose level 1
ALL (low tumor burden) dose level 2
CLL (ibrutinib) dose level 2
CLL dose level 1
CLL dose level 2
CLL dose level 3
NHL (dose dense) dose level 2
NHL dose level 1
NHL dose level 2
NHL dose level 3
Migration of Adoptively Transferred CD19 Chimeric Antigen Receptor (CAR)-T Cells
Migration of adoptively transferred CD19 chimeric antigen receptor (CAR)-T cells. Outcome will be reported for each of the 3 cohorts on the study. Outcome data is both count of patients with bone marrow disease involvement and count of patients with CAR-T cells detected in bone marrow at restaging.
Up to 1 year
Derived
Fiorenza S, Zheng Y, Purushe J, Bock TJ, Sarthy J, Janssens DH, Sheih AS, Kimble EL, Kirchmeier D, Phi TD, Gauthier J, Hirayama AV, Riddell SR, Wu Q, Gottardo R, Maloney DG, Yang JYH, Henikoff S, Turtle CJ. Histone marks identify novel transcription factors that parse CAR-T subset-of-origin, clinical potential and expansion. Nat Commun. 2024 Sep 27;15(1):8309. doi: 10.1038/s41467-024-52503-2.
Liang EC, Albittar A, Huang JJ, Hirayama AV, Kimble EL, Portuguese AJ, Chapuis A, Shadman M, Till BG, Cassaday RD, Milano F, Kiem HP, Riddell SR, Turtle CJ, Maloney DG, Gauthier J. Factors associated with long-term outcomes of CD19 CAR T-cell therapy for relapsed/refractory CLL. Blood Adv. 2023 Nov 28;7(22):6990-7005. doi: 10.1182/bloodadvances.2023011399.
Juluri KR, Wu QV, Voutsinas J, Hou J, Hirayama AV, Mullane E, Miles N, Maloney DG, Turtle CJ, Bar M, Gauthier J. Severe cytokine release syndrome is associated with hematologic toxicity following CD19 CAR T-cell therapy. Blood Adv. 2022 Apr 12;6(7):2055-2068. doi: 10.1182/bloodadvances.2020004142.
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Gauthier J, Bezerra ED, Hirayama AV, Fiorenza S, Sheih A, Chou CK, Kimble EL, Pender BS, Hawkins RM, Vakil A, Phi TD, Steinmetz RN, Jamieson AW, Bar M, Cassaday RD, Chapuis AG, Cowan AJ, Green DJ, Kiem HP, Milano F, Shadman M, Till BG, Riddell SR, Maloney DG, Turtle CJ. Factors associated with outcomes after a second CD19-targeted CAR T-cell infusion for refractory B-cell malignancies. Blood. 2021 Jan 21;137(3):323-335. doi: 10.1182/blood.2020006770.
Hirayama AV, Gauthier J, Hay KA, Voutsinas JM, Wu Q, Pender BS, Hawkins RM, Vakil A, Steinmetz RN, Riddell SR, Maloney DG, Turtle CJ. High rate of durable complete remission in follicular lymphoma after CD19 CAR-T cell immunotherapy. Blood. 2019 Aug 15;134(7):636-640. doi: 10.1182/blood.2019000905.
Hirayama AV, Gauthier J, Hay KA, Voutsinas JM, Wu Q, Gooley T, Li D, Cherian S, Chen X, Pender BS, Hawkins RM, Vakil A, Steinmetz RN, Acharya UH, Cassaday RD, Chapuis AG, Dhawale TM, Hendrie PC, Kiem HP, Lynch RC, Ramos J, Shadman M, Till BG, Riddell SR, Maloney DG, Turtle CJ. The response to lymphodepletion impacts PFS in patients with aggressive non-Hodgkin lymphoma treated with CD19 CAR T cells. Blood. 2019 Apr 25;133(17):1876-1887. doi: 10.1182/blood-2018-11-887067. Epub 2019 Feb 19.
Tuazon SA, Li A, Gooley T, Eunson TW, Maloney DG, Turtle CJ, Linenberger ML, Connelly-Smith LS. Factors affecting lymphocyte collection efficiency for the manufacture of chimeric antigen receptor T cells in adults with B-cell malignancies. Transfusion. 2019 May;59(5):1773-1780. doi: 10.1111/trf.15178. Epub 2019 Feb 6.
Hill JA, Li D, Hay KA, Green ML, Cherian S, Chen X, Riddell SR, Maloney DG, Boeckh M, Turtle CJ. Infectious complications of CD19-targeted chimeric antigen receptor-modified T-cell immunotherapy. Blood. 2018 Jan 4;131(1):121-130. doi: 10.1182/blood-2017-07-793760. Epub 2017 Oct 16.
Turtle CJ, Hanafi LA, Berger C, Gooley TA, Cherian S, Hudecek M, Sommermeyer D, Melville K, Pender B, Budiarto TM, Robinson E, Steevens NN, Chaney C, Soma L, Chen X, Yeung C, Wood B, Li D, Cao J, Heimfeld S, Jensen MC, Riddell SR, Maloney DG. CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients. J Clin Invest. 2016 Jun 1;126(6):2123-38. doi: 10.1172/JCI85309. Epub 2016 Apr 25.
FG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG002
ALL (High Tumor Burden) Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
FG00039 subjects
FG0015 subjects
FG0022 subjects
FG0031 subjects
FG00418 subjects
FG0055 subjects
FG00622 subjects
FG0071 subjects
FG00820 subjects
FG0095 subjects
FG01049 subjects
FG01110 subjects
FG01220 subjects
COMPLETED
FG0009 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG00411 subjects
FG0054 subjects
FG00610 subjects
FG0070 subjects
FG0089 subjects
FG0092 subjects
FG01017 subjects
FG0114 subjects
FG0127 subjects
NOT COMPLETED
FG00030 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG0047 subjects
FG0051 subjects
FG00612 subjects
FG0071 subjects
FG00811 subjects
FG0093 subjects
FG01032 subjects
FG0116 subjects
FG01213 subjects
Type
Comment
Reasons
Death
FG00027 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG0045 subjects
FG0051 subjects
FG00611 subjects
FG0071 subjects
FG00811 subjects
FG0093 subjects
FG01032 subjects
FG0116 subjects
FG01213 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient proceeded to new therapy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG002
ALL (High Tumor Burden) Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00039
BG0015
BG0022
BG0031
BG00418
BG0055
BG00622
BG0071
BG00820
BG0095
BG01049
BG01110
BG01220
BG013197
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0003
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00039
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy
Death within 8 weeks of the study cell infusion thought to be definitely or probably related to CAR T cell therapy will be assessed.
Posted
Count of Participants
Participants
Within 8 weeks of the study cell infusion
ID
Title
Description
OG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG002
ALL (High Tumor Burden) Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Units
Counts
Participants
OG00039
OG0015
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Dose Limiting Toxicities
Outcome will be reported as a count of participants that experienced a dose limiting toxicity on the study within 30 days post infusion.
Posted
Count of Participants
Participants
30 days
ID
Title
Description
OG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG002
ALL (High Tumor Burden) Dose Level 3
Primary
Objective Response Rate of Complete Response and Partial Response
Outcome will be reported as the count of patients per arm that experienced a complete response/partial response.
Complete response (CR): CR per Lugano criteria for nodal disease and minimal residual disease (MRD)-negative CR by flow cytometry for marrow disease.
Partial response (PR): > 50% reduction of the sum of the products of the perpendicular diameters of marker lesions, no progression of any existing lesions, and no new lesions.
Posted
Count of Participants
Participants
Up to 1 year
ID
Title
Description
OG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Primary
Overall Survival
Outcome will be reported as a count of patients who survived up to 1 year post infusion.
Posted
Count of Participants
Participants
Up to 1 year
ID
Title
Description
OG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG002
ALL (High Tumor Burden) Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Primary
Progression Free Survival
Outcome will be reported as the count of patients per arm that survived and whose disease did not progress in the 1 year timeframe post infusion.
Posted
Count of Participants
Participants
Up to 1 year
ID
Title
Description
OG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG002
ALL (High Tumor Burden) Dose Level 3
Secondary
Duration of Persistence of Adoptively Transferred CD19 Chimeric Antigen Receptor (CAR)-T Cells
Duration of persistence of adoptively transferred CD19 chimeric antigen receptor (CAR)-T cells. Outcome will be reported for each of the 3 cohorts on the study. Outcome data is both count of patients alive after 1 year and count of patients with CAR-T cells detected at 1 year.
Cohorts for this outcome are combined into disease type. The first row is a count of participants that were alive at the 1 year post infusion point within these cohorts. The second row is a count of participants who had CAR-T cells present at the 1 year follow up. This count has a lower number analyzed because it is out of the participants who had available CAR-T data at the 1 year followup timepoint.
Posted
Count of Participants
Participants
Up to day 365
ID
Title
Description
OG000
Acute Lymphocytic Leukemia Cohort
Cohort containing all ALL subtypes and treatment dose levels.
OG001
Non-Hodgkin Lymphoma Cohort
Cohort containing all NHL subtypes and treatment dose levels.
OG002
Chronic Lymphocytic Leukemia Cohort
Cohort containing all CLL subtypes and treatment dose levels.
Secondary
Migration of Adoptively Transferred CD19 Chimeric Antigen Receptor (CAR)-T Cells
Migration of adoptively transferred CD19 chimeric antigen receptor (CAR)-T cells. Outcome will be reported for each of the 3 cohorts on the study. Outcome data is both count of patients with bone marrow disease involvement and count of patients with CAR-T cells detected in bone marrow at restaging.
This outcome is split into arms by disease type. The first row is a count of participants out of those treated that had bone marrow disease involvement. The second row reports the count of participants with CAR-T cells detected in bone marrow at restaging. The total number analyzed for the count of participants with CAR-T cells detected in bone marrow at restaging is lower than the overall number analyzed because it is those who had available bone marrow data at the time of restaging.
Posted
Count of Participants
Participants
Up to 1 year
ID
Title
Description
OG000
Acute Lymphocytic Leukemia Cohort
Cohort containing all ALL subtypes and treatment dose levels.
OG001
Non-Hodgkin Lymphoma Cohort
Cohort containing all NHL subtypes and treatment dose levels.
OG002
Chronic Lymphocytic Leukemia Cohort
Time Frame
Adverse events will be assessed up to 1 year for each patient following their infusion.
Description
Adverse Events will be extracted from the patient record and assessed by the Principle Investigator for relation to treatment. AEs will beb graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.03).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ALL (High Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
27
39
39
39
39
39
EG001
ALL (High Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
3
5
5
5
5
5
EG002
ALL (High Tumor Burden) Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
1
2
2
2
2
2
EG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
1
1
0
1
1
1
EG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
5
18
14
18
18
18
EG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
1
5
5
5
5
5
EG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
11
22
22
22
22
22
EG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
1
1
1
1
1
1
EG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
11
20
20
20
20
20
EG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
3
5
5
5
5
5
EG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
32
49
49
49
49
49
EG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
6
10
7
10
10
10
EG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
13
20
20
20
19
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Disseminated intravascular coagulation
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected1 at risk
EG004
Febrile neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG00042 events30 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac arrest
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Heart failure
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Left ventricular systolic dysfunction
Cardiac disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Pericardial tamponade
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sick sinus syndrome
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sinus bradycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Anal fistula
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Gastric hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Fever
General disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0013 events3 affected5 at risk
EG0021 events1 affected2 at risk
EG003
General disorders and administration site conditions - Other, specify
General disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Multi-organ failure
General disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Sudden death NOS
General disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hepatic failure
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Cytokine release syndrome
Immune system disorders
Systematic Assessment
EG00010 events10 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Anorectal infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Bone infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Catheter related infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
Systematic Assessment
EG0003 events3 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Lung infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
White blood cell decreased
Investigations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Tumor lysis syndrome
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Central nervous system necrosis
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Cognitive disturbance
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Depressed level of consciousness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Dysarthria
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Dysphasia
Nervous system disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Edema cerebral
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Encephalopathy
Nervous system disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0013 events3 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Stroke
Nervous system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Delirium
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Suicide attempt
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Renal and urinary disorders - Other, specify
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Laryngeal edema
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary edema
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Capillary leak syndrome
Vascular disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0009 events9 affected39 at risk
EG0015 events5 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
Systematic Assessment
EG00044 events33 affected39 at risk
EG0014 events4 affected5 at risk
EG0021 events1 affected2 at risk
EG0032 events1 affected1 at risk
EG00415 events12 affected18 at risk
EG0056 events3 affected5 at risk
EG00627 events19 affected22 at risk
EG0071 events1 affected1 at risk
EG00819 events16 affected20 at risk
EG0096 events4 affected5 at risk
EG01046 events32 affected49 at risk
EG0117 events6 affected10 at risk
EG01220 events14 affected20 at risk
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0003 events3 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sinus bradycardia
Cardiac disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0006 events5 affected39 at risk
EG0014 events4 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hemorrhoidal hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Lower gastrointestinal hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Rectal pain
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Edema limbs
General disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Fever
General disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
General disorders and administration site conditions - Other, specify
General disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Localized edema
General disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Cytokine release syndrome
Immune system disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Anorectal infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Catheter related infection
Infections and infestations
Systematic Assessment
EG0003 events3 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
Systematic Assessment
EG0003 events3 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Lung infection
Infections and infestations
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Pancreas infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
Systematic Assessment
EG0008 events8 affected39 at risk
EG0013 events3 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0004 events4 affected39 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Alkaline phosphatase increased
Investigations
Systematic Assessment
EG0003 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0004 events4 affected39 at risk
EG0013 events3 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Cardiac troponin I increased
Investigations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
CPK increased
Investigations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Creatinine increased
Investigations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Ejection fraction decreased
Investigations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Electrocardiogram QT corrected interval prolonged
Investigations
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Fibrinogen decreased
Investigations
Systematic Assessment
EG0006 events6 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
GGT increased
Investigations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Lipase increased
Investigations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
Systematic Assessment
EG00058 events39 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Lymphocyte count increased
Investigations
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG00059 events39 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG00052 events29 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Urine output decreased
Investigations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Weight gain
Investigations
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
White blood cell decreased
Investigations
Systematic Assessment
EG00056 events39 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Acidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Anorexia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG00012 events9 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0013 events3 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 events2 affected39 at risk
EG0014 events4 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
Systematic Assessment
EG0005 events5 affected39 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
Systematic Assessment
EG00010 events7 affected39 at risk
EG0015 events5 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
Systematic Assessment
EG00016 events15 affected39 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected2 at risk
EG003
Tumor lysis syndrome
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0004 events4 affected39 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected2 at risk
EG003
Muscle weakness left-sided
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected2 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Units
Counts
Participants
OG00039
OG0015
OG0022
OG0031
OG00418
OG0055
OG00622
OG0071
OG00820
OG0095
OG01049
OG01110
OG01220
Title
Denominators
Categories
Title
Measurements
OG0003
OG0011
OG0021
OG0030
OG0042
OG0050
OG0064
OG0070
OG0081
OG0090
OG0100
OG0113
OG0120
OG002
ALL (High Tumor Burden) Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Units
Counts
Participants
OG00039
OG0015
OG0022
OG0031
OG00418
OG0055
OG00622
OG0071
OG00820
OG0095
OG01049
OG01110
OG01220
Title
Denominators
Categories
Title
Measurements
OG00032
OG0015
OG0021
OG0031
OG00418
OG0054
OG00616
OG0071
OG00812
OG0092
OG01028
OG0114
OG01210
OG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Units
Counts
Participants
OG00039
OG0015
OG0022
OG0031
OG00418
OG0055
OG00622
OG0071
OG00820
OG0095
OG01049
OG01110
OG01220
Title
Denominators
Categories
Title
Measurements
OG00012
OG0012
OG0021
OG0030
OG00413
OG0054
OG00613
OG0070
OG0089
OG0092
OG01020
OG0114
OG0127
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG003
ALL (Low Tumor Burden) Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG004
ALL (Low Tumor Burden) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG005
CLL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG006
CLL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG007
CLL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG008
CLL (Ibrutinib) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG009
NHL Dose Level 1
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG010
NHL Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG011
NHL Dose Level 3
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
OG012
NHL (Dose Dense) Dose Level 2
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.
Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg
Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV
Units
Counts
Participants
OG00039
OG0015
OG0022
OG0031
OG00418
OG0055
OG00622
OG0071
OG00820
OG0095
OG01049
OG01110
OG01220
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0041
OG0053
OG0064
OG0070
OG0082
OG0090
OG0104
OG0111
OG0122
Units
Counts
Participants
OG00065
OG00184
OG00248
Title
Denominators
Categories
Count of patients alive 1 year after CAR-T cell infusion
ParticipantsOG00065
ParticipantsOG00184
ParticipantsOG00248
Title
Measurements
OG00033
OG00146
OG00223
Count of patients with CAR-T cells detected at 1 year
ParticipantsOG00029
ParticipantsOG00134
ParticipantsOG00222
Title
Measurements
OG000
Cohort containing all CLL subtypes and treatment dose levels.
Units
Counts
Participants
OG00065
OG00184
OG00248
Title
Denominators
Categories
Count of patients with bone marrow disease involvement
ParticipantsOG00065
ParticipantsOG00184
ParticipantsOG00248
Title
Measurements
OG00062
OG00124
OG00247
Count of patients with CAR-T cells detected in bone marrow at restaging