A Safety and Efficacy Study Evaluating CTX110 in Subjects... | NCT04035434 | Trialant
NCT04035434
Sponsor
CRISPR Therapeutics AG
Status
Terminated
Last Update Posted
Oct 24, 2025Actual
Enrollment
93Actual
Phase
Phase 1Phase 2
Conditions
B-cell Malignancy
Non-Hodgkin Lymphoma
B-cell Lymphoma
Adult B Cell ALL
Interventions
CTX110
Countries
United States
Australia
Canada
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT04035434
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CRSP-ONC-001
Secondary IDs
Not provided
Brief Title
A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Official Title
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Acronym
Not provided
Organization
CRISPR TherapeuticsINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Patients to be followed up in the CRSP-ONC-LTF study
Expanded Access Info
No
Start Date
Jul 22, 2019Actual
Primary Completion Date
Oct 4, 2024Actual
Completion Date
Oct 4, 2024Actual
First Submitted Date
Jul 22, 2019
First Submission Date that Met QC Criteria
Jul 25, 2019
First Posted Date
Jul 29, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jul 8, 2025
Results First Submitted that Met QC Criteria
Oct 9, 2025
Results First Posted Date
Oct 24, 2025Actual
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
Oct 9, 2025
Last Update Posted Date
Oct 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CRISPR Therapeutics AGINDUSTRY
Collaborators
Not provided
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 is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
Detailed Description
The study may enroll up to 227 subjects in total. CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
Conditions Module
Conditions
B-cell Malignancy
Non-Hodgkin Lymphoma
B-cell Lymphoma
Adult B Cell ALL
Keywords
CAR T
Non-Hodgkin Lymphoma
NHL
Lymphoma
Allogeneic
Leukemia
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
93Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CTX110
Experimental
Administered by IV infusion following lymphodepleting chemotherapy.
Biological: CTX110
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CTX110
Biological
CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components
CTX110
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment [e.g., 1 mg/kg/day], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
Up to 28 days
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Up to 5 years
Secondary Outcomes
Measure
Description
Time Frame
Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population
The objective response rate (complete response + complete remission with incomplete blood count recovery) was analyzed as per response criteria adapted from the National Comprehensive Cancer Network guidelines for treatment of acute lymphoblastic leukemia Version 2.2021, as determined by independent central radiology review. For -participants who receive the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
Eastern Cooperative Oncology Group performance status 0 or 1.
Adequate renal, liver, cardiac and pulmonary organ function
Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX110 infusion.
Key Exclusion Criteria:
For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
History of central nervous system (CNS) involvement by malignancy
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
Presence of bacterial, viral, or fungal infection that is uncontrolled.
Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of CTX110 infusion. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of CTX110 infusion.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
McGuirk JP, Ghobadi A, Bachier CR, Shaughnessy PJ, Awan FT, Maakaron JE, Bishop MR, Ho PJ, Tam CS, Dickinson MJ, Darrah JM, Waller EK, Murthy HS, Ross A, Williams LM, Pan C, Stevens WN, Serwer L, Nguyen T, Terrett J, Kalaitzidis D, Ma A, Xu H, Benton MD, Weaver A, Cohen SB, Maziarz RT, Cheah CY. Safety and efficacy of allogeneic CD19-directed CAR-T therapy CTX110 in relapsed/refractory B-cell non-Hodgkin lymphoma. Blood Adv. 2026 May 5:bloodadvances.2026020123. doi: 10.1182/bloodadvances.2026020123. Online ahead of print.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study was designed to be divided into 2 phases. A total of 8 participants were enrolled in the Phase 2 dose expansion. Due to a high proportion of non-quantifiable values, the secondary efficacy endpoints for Phase 2 participants could not be calculated. The study was terminated early in Phase 2 at the sponsor's discretion.
Recruitment Details
The study comprises 4 cohorts: Cohorts A, B, and C enrolled adult participants with non-Hodgkin lymphoma (NHL); Cohort D enrolled participants with adult B cell acute lymphoblastic leukemia (ALL). A total of 93 participants were enrolled; 3 participants died prior to receiving CTX110 (1 due to pulmonary haemorrhage that occurred after lymphodepleting [LD] chemotherapy but was assessed as not related to LD chemotherapy, and 2 due to disease progression).
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Periods
Title
Milestones
Reasons Not Completed
Dose Escalation Phase (Up to 5 Years)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
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
Sep 12, 2022
Jul 8, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Sequential 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
Up to 5 years
Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population
Duration of response was only reported for the participants who showed objective response events. This was calculated as the time between first objective response and date of disease progression or death due to any cause. Median duration of response was calculated with the Kaplan-Meier method. Confidence intervals of median duration of response were calculated with the Brookmeyer and Crowley method with log-log transformation.
Up to 5 years
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population
Progression-free survival (PFS) and event-free survival were calculated as the difference between date of CTX110 infusion and date of disease progression or death due to any cause. The median of PFS was calculated with the Kaplan-Meier method. The CIs of median PFS were calculated with the Brookmeyer and Crowley method with log-log transformation.
Up to 5 years
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population
Overall survival was calculated as the time between date of first dose of CTX110 and death due to any cause. Participants who are alive at the data cutoff date will be censored at their last date known to be alive. Median overall survival was calculated with the Kaplan-Meier method. CIs of median overall survival were calculated with the Brookmeyer and Crowley method with log-log transformation.
Up to 5 years
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population
A TEAE was any untoward medical occurrence or worsening of a pre-existing condition in a clinical trial participant who received the investigational medicinal product, regardless of a causal relationship with the treatment. An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Up to 5 years
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Blood samples were collected for the analysis of laboratory parameters including hematology, clinical chemistry and coagulation parameters. The hematology parameters included: Lymphocyte count decreased, Neutrophil count decreased, White blood cell decreased, Anemia, Platelet count decreased, leukocytosis and Lymphocyte count increased. Chemistry parameters included: Hypoalbuminemia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Hypokalemia, Chronic kidney disease, Blood bilirubin increased, Creatinine increased, Hypermagnesemia, Hypernatremia, Hypercalcemia, Hyperkalemia, and Hypoglycemia. Coagulation parameters included: Activated partial thromboplastin time prolonged, Fibrinogen decreased, and INR increased. Grade 3 and above severity of laboratory abnormalities are considered as clinically significant laboratory abnormalities.
Up to 5 years
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid [DNA]) over time following the first CTX110 infusion. Cohort A DL4a and DL4b were combined, as the same dose was administered. Mean concentration values of CTX110 have been presented by dose level.
Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid [DNA]) over time following the first CTX110 infusion.
Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population
An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Up to 5 years
San Francisco
California
94143
United States
Mayo Clinic
Jacksonville
Florida
32224
United States
Emory University Winship Cancer Institute
Atlanta
Georgia
30322
United States
University of Chicago
Chicago
Illinois
60637
United States
University of Kansas
Westwood
Kansas
66205
United States
Markey Cancer Center, University of Kentucky
Lexington
Kentucky
40536
United States
University of Maryland
Baltimore
Maryland
21201
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
University of Minnesota
Minneapolis
Minnesota
55455
United States
Washington University
St Louis
Missouri
63130
United States
Roswell Park Cancer Insitute
Buffalo
New York
14203
United States
Weill Cornell Medical College / New York Presbyterian Hospital
New York
New York
10021
United States
Duke University
Durham
North Carolina
27710
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center
Dallas
Texas
75390
United States
Texas Transplant Institute
San Antonio
Texas
78229
United States
Virginia Commonwealth University Massey Cancer Center
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
FG010
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
FG011
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
FG012
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG00410 subjects
FG0054 subjects
FG0060 subjects
FG0071 subjects
FG0085 subjects
FG0095 subjects
FG0104 subjects
FG0115 subjects
FG0127 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG00410 subjects
FG0054 subjects
FG0060 subjects
FG0071 subjects
FG0085 subjects
FG0095 subjects
FG0104 subjects
FG0115 subjects
FG0127 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
Death
FG0003 subjects
FG0011 subjects
FG0024 subjects
FG0033 subjects
FG004
Study terminated by the Sponsor
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Dose Expansion Phase (Up to 5 Years)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00523 subjects
FG0068 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full Analysis Set: All participants who received CTX110 infusion.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
BG001
Cohort A: DL 2 (1x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
BG002
Cohort A: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
BG003
Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
BG004
Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
BG005
Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
BG006
Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
BG007
Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
BG008
Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
BG009
B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
BG010
B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
BG011
B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0026
BG0036
BG00410
BG00535
BG0061
BG0075
BG0085
BG0094
BG0105
BG0117
BG01290
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00054.3± 5.86
BG00165.3± 8.08
BG00268.2± 5.34
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment [e.g., 1 mg/kg/day], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
DLT Evaluable Set comprised of participants who received CTX110 and are followed for at least 28 days post-infusion or withdraw consent after experiencing a DLT.
Posted
Count of Participants
Participants
Up to 28 days
ID
Title
Description
OG000
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3*10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
OG009
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
OG010
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
OG011
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population
The objective response rate (complete response + complete remission with incomplete blood count recovery) was analyzed as per response criteria adapted from the National Comprehensive Cancer Network guidelines for treatment of acute lymphoblastic leukemia Version 2.2021, as determined by independent central radiology review. For -participants who receive the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 5 years
ID
Title
Description
OG000
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
OG001
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Secondary
Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population
Duration of response was only reported for the participants who showed objective response events. This was calculated as the time between first objective response and date of disease progression or death due to any cause. Median duration of response was calculated with the Kaplan-Meier method. Confidence intervals of median duration of response were calculated with the Brookmeyer and Crowley method with log-log transformation.
Full Analysis Set: Participants who reported objective response events were analyzed. The duration of response for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
Posted
Median
95% Confidence Interval
Months
Up to 5 years
ID
Title
Description
OG000
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Secondary
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population
Progression-free survival (PFS) and event-free survival were calculated as the difference between date of CTX110 infusion and date of disease progression or death due to any cause. The median of PFS was calculated with the Kaplan-Meier method. The CIs of median PFS were calculated with the Brookmeyer and Crowley method with log-log transformation.
Full Analysis Set: Participants who reported PFS events were analyzed. The progression free survival for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
Posted
Median
95% Confidence Interval
Months
Up to 5 years
ID
Title
Description
OG000
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Secondary
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population
Overall survival was calculated as the time between date of first dose of CTX110 and death due to any cause. Participants who are alive at the data cutoff date will be censored at their last date known to be alive. Median overall survival was calculated with the Kaplan-Meier method. CIs of median overall survival were calculated with the Brookmeyer and Crowley method with log-log transformation.
Full Analysis Set: Participants reporting overall survival rate were analyzed. The median overall survival for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
Posted
Median
95% Confidence Interval
Months
Up to 5 years
ID
Title
Description
OG000
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Secondary
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population
A TEAE was any untoward medical occurrence or worsening of a pre-existing condition in a clinical trial participant who received the investigational medicinal product, regardless of a causal relationship with the treatment. An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
Posted
Count of Participants
Participants
Up to 5 years
ID
Title
Description
OG000
Phase1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Secondary
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Blood samples were collected for the analysis of laboratory parameters including hematology, clinical chemistry and coagulation parameters. The hematology parameters included: Lymphocyte count decreased, Neutrophil count decreased, White blood cell decreased, Anemia, Platelet count decreased, leukocytosis and Lymphocyte count increased. Chemistry parameters included: Hypoalbuminemia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Hypokalemia, Chronic kidney disease, Blood bilirubin increased, Creatinine increased, Hypermagnesemia, Hypernatremia, Hypercalcemia, Hyperkalemia, and Hypoglycemia. Coagulation parameters included: Activated partial thromboplastin time prolonged, Fibrinogen decreased, and INR increased. Grade 3 and above severity of laboratory abnormalities are considered as clinically significant laboratory abnormalities.
Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
Posted
Count of Participants
Participants
Up to 5 years
ID
Title
Description
OG000
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Secondary
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid [DNA]) over time following the first CTX110 infusion. Cohort A DL4a and DL4b were combined, as the same dose was administered. Mean concentration values of CTX110 have been presented by dose level.
Full Analysis Set. Only those participants with data available at specified timepoints has been presented.
Posted
Mean
Standard Deviation
Copies per micrograms DNA
Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Secondary
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid [DNA]) over time following the first CTX110 infusion.
Full Analysis Set
Posted
Mean
Standard Deviation
Copies per micrograms DNA
Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2
ID
Title
Description
OG000
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
OG001
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Secondary
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population
An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
Posted
Count of Participants
Participants
Up to 5 years
ID
Title
Description
OG000
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Time Frame
Up to 5 years
Description
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
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
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10^7 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
4
5
4
5
5
5
EG009
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
4
4
3
4
4
4
EG010
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
2
5
3
5
5
5
EG011
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
B Cell ALL: Cohort D: DL 4 (6*10^8 CAR+ T Cells) Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
1
7
1
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BG00659.0± NANA indicates standard deviation cannot be calculated for single participant
BG00771.0± 8.43
BG00863.8± 6.65
BG00935.0± 10.30
BG01039.4± 13.83
BG01147.7± 17.61
BG01260.0± 14.50
4
BG0032
BG0042
BG0059
BG0060
BG0072
BG0082
BG0091
BG0102
BG0113
BG01229
Male
BG0002
BG0012
BG0022
BG0034
BG0048
BG00526
BG0061
BG0073
BG0083
BG0093
BG0103
BG0114
BG01261
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Asian
BG0001
BG0011
BG0020
BG0030
BG0040
BG0052
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0125
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Black or African American
BG0000
BG0010
BG0020
BG0031
BG0041
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0124
White
BG0002
BG0012
BG0026
BG0034
BG0047
BG00530
BG0061
BG0075
BG0084
BG0094
BG0104
BG0116
BG01275
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0042
BG0052
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0126
6
OG00410
OG0054
OG0061
OG0075
OG0085
OG0094
OG0105
OG0117
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Units
Counts
Participants
OG00023
OG0018
Title
Denominators
Categories
Title
Measurements
OG00060.9(38.5 to 80.3)
OG00175.0(34.9 to 96.8)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
OG002
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Units
Counts
Participants
OG0000
OG0011
OG0024
OG0034
OG0047
OG00516
OG0061
OG0073
OG0082
Title
Denominators
Categories
Title
Measurements
OG0019.20(NA to NA)Due to smaller number of events, 95% CI could not be calculated.
OG0023.75(1.68 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0033.52(0.95 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0041.02(0.46 to 1.31)
OG0053.60(1.91 to 8.57)
OG006NA(NA to NA)NA indicates single participant did not allow meaningful calculation of median and its 95% CI.
OG0072.20(2.00 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0081.56(1.05 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG00410
OG00527
OG0061
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG0000.92(0.79 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0011.91(0.85 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0022.43(0.95 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0031.54(0.82 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0041.77(0.76 to 2.10)
OG0052.83(1.02 to 3.94)
OG006NA(NA to NA)NA indicates single participant did not allow meaningful calculation of median and its 95% CI.
OG0072.92(0.79 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0081.94(0.92 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG00410
OG00527
OG0061
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG0005.03(2.73 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG00137.16(1.05 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0027.77(2.96 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG003NA(1.61 to NA)Due to smaller number of events, the median and upper 95% CI could not be calculated.
OG0045.16(1.71 to 27.73)
OG00514.26(4.47 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG00612.12(NA to NA)Due to smaller number of events, 95% CI could not be calculated.
OG0077.39(1.18 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
OG0087.62(1.71 to NA)Due to smaller number of events, upper 95% CI could not be calculated.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
OG009
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells
OG010
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
OG011
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
OG009
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells.
OG010
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
B Cell ALL: Cohort D: DL 3 (3*10^8 CAR+ T Cells) Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
OG011
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells. Cohort A DL4a and DL4b were combined for pharmacokinetic analysis as same dose of CTX110 was administered
Units
Counts
Participants
OG0006
OG0016
OG0021
OG0035
OG0045
OG00545
Title
Denominators
Categories
Day 1 pre-infusion
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0043
ParticipantsOG00543
Title
Measurements
OG0002.90± 0.000
OG0013.55± 1.592
OG0022.90± NAThe standard deviation cannot be calculated for single participant
OG003
Day 1 post-infusion
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0032
Day 2
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0033
Day 3
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0033
Day 5
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0034
Day 8
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0033
Day 10
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0035
Day 14
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0035
Day 21
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0034
Day 28
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0035
Month 2
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Month 3
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Month 6
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Month 9
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Month 12
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
Month 24
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
OG002
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
B Cell ALL: Cohort D: DL 4 (6*10^8 CAR+ T Cells) Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10^8 CAR+ T cells.
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
OG009
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10^8 CAR+ T cells
OG010
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10^8 CAR+ T cells.
OG011
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10^8 CAR+ T cells.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG00410
OG00535
OG0061
OG0075
OG0085
OG0094
OG0105
OG0117
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0021
OG0031
OG0045
OG0058
OG0060
OG0071
OG0084
OG0093
OG0103
OG0111
0 affected
10 at risk
EG0053 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0051 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0042 affected10 at risk
EG0052 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0051 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0071 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
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0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
1 affected
6 at risk
EG0042 affected10 at risk
EG0053 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0081 affected5 at risk
EG0091 affected4 at risk
EG0100 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0052 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected5 at risk
EG0110 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected35 at risk
EG0060 affected1 at risk
EG0070 affected5 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected5 at risk
EG0111 affected7 at risk
6
OG00410
OG00535
OG0061
OG0075
OG0085
OG0094
OG0105
OG0117
6
OG00410
OG00535
OG0061
OG0075
OG0085
OG0094
OG0105
OG0117
3
OG0048
OG00517
OG0060
OG0072
OG0083
OG0092
OG0103
OG0113
4
OG0046
OG00519
OG0061
OG0072
OG0085
OG0092
OG0103
OG0113
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG0101
OG0110
1
OG0040
OG0050
OG0060
OG0072
OG0080
OG0090
OG0100
OG0111
0
OG0040
OG0053
OG0060
OG0072
OG0080
OG0090
OG0100
OG0112
0
OG0041
OG0052
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0041
OG0051
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0041
OG0051
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0054
OG0060
OG0071
OG0081
OG0091
OG0101
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
2.90
± 0.000
OG0042.90± 0.000
OG0053.08± 0.934
ParticipantsOG0044
ParticipantsOG00542
Title
Measurements
OG000144.95± 147.856
OG001829.37± 1552.483
OG002472.20± NAThe standard deviation cannot be calculated for single participant
OG003105.22± 23.028
OG004636.29± 352.700
OG005979.25± 1658.499
Participants
OG004
4
ParticipantsOG00542
Title
Measurements
OG0007.27± 6.403
OG00110.77± 13.999
OG00228.57± NAThe standard deviation cannot be calculated for single participant
OG00335.62± 22.359
OG00472.39± 107.323
OG00542.39± 101.461
Participants
OG004
3
ParticipantsOG00539
Title
Measurements
OG0008.36± 5.310
OG00112.46± 9.656
OG00222.03± NAThe standard deviation cannot be calculated for single participant
OG00316.76± 13.050
OG004204.43± 300.219
OG00535.80± 98.739
Participants
OG004
4
ParticipantsOG00538
Title
Measurements
OG00025.47± 21.898
OG001220.78± 246.411
OG002311.67± NAThe standard deviation cannot be calculated for single participant
OG00380.40± 33.878
OG004487.13± 262.303
OG005770.14± 3312.713
Participants
OG004
2
ParticipantsOG00539
Title
Measurements
OG0003763.68± 8138.642
OG0014337.42± 7721.088
OG00213269.43± NAThe standard deviation cannot be calculated for single participant
OG0035844.98± 9600.631
OG004719.13± 231.318
OG00510277.87± 27526.126
Participants
OG004
5
ParticipantsOG00539
Title
Measurements
OG000180.87± 209.131
OG001452.03± 941.853
OG00225719.13± NAThe standard deviation cannot be calculated for single participant
OG00319018.53± 42303.294
OG004297.91± 248.623
OG0054056.03± 19737.607
Participants
OG004
4
ParticipantsOG00540
Title
Measurements
OG0002.90± 0.000
OG0013.55± 1.592
OG0029.93± NAThe standard deviation cannot be calculated for single participant
OG0032435.23± 5423.525
OG00451.73± 87.882
OG0052186.81± 13766.282
Participants
OG004
4
ParticipantsOG00541
Title
Measurements
OG0002.90± 0.000
OG0012.90± 0.000
OG0022.90± NAThe standard deviation cannot be calculated for single participant
OG00364.48± 123.167
OG0043.88± 1.950
OG0052537.64± 11074.754
Participants
OG004
4
ParticipantsOG00537
Title
Measurements
OG0004.00± 2.452
OG0012.90± 0.000
OG0022.90± NAThe standard deviation cannot be calculated for single participant
OG0036.67± 8.437
OG0042.90± NAThe standard deviation cannot be calculated for single participant
OG0058.32± 28.058
Participants
OG004
1
ParticipantsOG0055
Title
Measurements
OG0003.88± 1.379
OG0012.90± 0.000
OG002NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
OG00311.17± 14.318
OG0042.90± NAThe standard deviation cannot be calculated for single participant
OG0052.90± 0.000
Participants
OG004
1
ParticipantsOG0051
Title
Measurements
OG0003.55± 1.126
OG0012.90± 0.000
OG002NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
OG0032.90± 0.000
OG0042.90± NAThe standard deviation cannot be calculated for single participant
OG0052.90± NAThe standard deviation cannot be calculated for single participant
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0002.90± 0.000
OG0012.90± NAThe standard deviation cannot be calculated for single participant
OG002NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0012.90± NAThe standard deviation cannot be calculated for single participant
OG002NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0012.90± NAThe standard deviation cannot be calculated for single participant
OG002NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
OG0032.90± NAThe standard deviation cannot be calculated for single participant
OG0042.90± NAThe standard deviation cannot be calculated for single participant
Participants
OG004
5
ParticipantsOG0050
Title
Measurements
OG0012.90± NAThe standard deviation cannot be calculated for single participant
OG002NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
OG003NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
OG004NA± NAMean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
781.86
± 1395.907
OG0011983.57± 1677.746
OG002602.75± 521.357
4.20
± 2.252
OG00193.47± 149.220
OG00218.13± 17.532
13.46
± 14.905
OG00120.47± 25.356
OG0027.95± 4.705
28.65
± 36.011
OG00142.37± 47.444
OG00262.85± 124.743
71.30
± 118.215
OG00116846.17± 33459.507
OG00215941.89± 30200.959
226.32
± 290.508
OG00126.17± 41.517
OG00214177.59± 23256.089
1040.13
± 1466.869
OG0012.90± 0.000
OG002380.29± 924.424
3.55
± 1.126
OG0012.90± 0.000
OG0022.90± 0.000
2.90
± 0.000
OG0012.90± 0.000
OG0022.90± 0.000
2.90
± NA
The standard deviation cannot be calculated for single participant
OG0012.90± NAThe standard deviation cannot be calculated for single participant
OG0022.90± NAThe standard deviation cannot be calculated for single participant