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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01932 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9762 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| RG9217023 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P01CA018029 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count in the blood, which may help the infused BCMA CAR-T cells survive and expand.
PRIMARY OBJECTIVE:
I. To evaluate the safety of adoptive therapy with ex vivo expanded autologous CD8+ plus CD4+ T cells transduced to express a human B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) for patients with relapsed or treatment refractory multiple myeloma.
SECONDARY OBJECTIVES:
I. To determine the duration of in vivo persistence and the phenotype of long lived CAR-T cells.
II. To determine the degree to which adoptively transferred T cells traffic to multiple myeloma (MM) cells in the bone marrow (BM) and function in vivo.
III. To estimate the antitumor activity of adoptively transferred BCMA-specific CAR-expressing T lymphocytes (BCMA CAR-T cells).
OUTLINE: This is a dose-escalation study of BCMA-specific CAR-expressing T lymphocytes.
Patients undergo leukapheresis to obtain their immune cells, from which CAR-T cells are produced. A few weeks later, patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning 36-96 hours after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes intravenously (IV) over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator).
After completion of study treatment, patients are followed up at 60, 90, 120, 180, and 365 days and then annually up to 15 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy, BCMA CAR-T cells) at dose level 1 | Experimental | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10^6 EGFRt cells) |
|
| Treatment (chemotherapy, BCMA CAR-T cells) at dose level 2 | Experimental | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10^6 EGFRt cells) |
|
| Treatment (chemotherapy, BCMA CAR-T cells) at dose level 3 | Experimental | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicities (DLT) Rate | Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome will be reported as count of participants in each arm who experienced a DLT. No patients received more than one CAR T cell infusion, so DLT assessment period was only 28 days after first and only CAR T infusion for all patients. | Up to 28 days after CAR T cell infusion |
| Count of Patients That Experienced Adverse Events | Toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. | Up to 28 days after CAR T-cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells | Persistence of CART cells is tested by qPCR in PBMC. | Assessed from Baseline up to a maximum of 537 days |
| Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28 |
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Inclusion Criteria:
Have the capacity to give informed consent
Eastern Cooperative Oncology Group (ECOG) performance status score =< 2.
Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
Have a diagnosis of BCMA+ MM (>= 5% BCMA+ by flow cytometry on CD138 co-expressing plasma cells obtained within 45 days of study enrollment); the MM diagnosis must be confirmed by internal pathology review of a fresh biopsy specimen at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)
Have relapsed or treatment refractory disease with >= 10% CD138+ malignant plasma cells (IHC) on BM core biopsy, either:
Following autologous stem cell transplant (ASCT)
Or, if a patient has not yet undergone ASCT, the individual must:
Be transplant ineligible, due to age, comorbidity, patient choice, insurance reasons, concerns of rapidly progressive disease, and/or discretion of attending physician and principal investigator and,
Demonstrate disease that persists after > 4 cycles of induction therapy and that is double refractory (persistence/progression) after therapy with both a proteasome inhibitor and immunomodulatory drug (IMiD) administered either in tandem, or in sequence; > 4 cycles of therapy are not required for patients with a diagnosis of plasma cell leukemia
Male and female patients of reproductive potential must be willing to use an effect contraceptive method before, during, and for at least 4 months after the CAR T cell infusion
Exclusion Criteria:
History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year (the following are exempt from the 1 year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)
Active hepatitis B, hepatitis C at the time of screening
Patients who are (human immunodeficiency virus [HIV]) seropositive
Subjects with uncontrolled active infection
> 1 hospital admission (lasting 5 days or more) for documented infection in prior 6 months
Presence of acute or chronic graft-versus-host disease (GVHD) requiring active treatment unless limited to skin involvement and managed with topical steroid therapy alone
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease as determined by the principal investigator (PI) or designee
History of clinically relevant or active central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis, active central nervous system MM involvement and/or carcinomatous meningitis; subjects with previously treated central nervous systems involvement may participate, provided they are free of disease in the CNS (documented by flow cytometry performed on the cerebrospinal fluid [CSF] within 14 days of enrollment) and have no evidence of new sites of CNS activity
Pregnant or breastfeeding females
Allogeneic HSCT or donor lymphocyte infusion within 90 days of leukapheresis.
Use of any of the following:
Absolute neutrophil count (ANC) < 1000/mm^3, or per PI discretion if cytopenia thought to be related to underlying myeloma.
Hemoglobin (Hgb) < 8 mg/dl, or per PI discretion if cytopenia thought to be related to underlying myeloma.
Platelet count < 50,000/mm^3, or per PI discretion if cytopenia thought to be related to underlying myeloma.
Active autoimmune disease requiring immunosuppressive therapy
Major organ dysfunction defined as:
Anticipated survival of < 3 months
Contraindication to cyclophosphamide or fludarabine chemotherapy
Patients with known AL subtype amyloidosis
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the PI; or unwillingness or inability to follow the procedures required in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Damian J. Green | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40198877 | Derived | Tuazon SA, Portuguese AJ, Pont MJ, Cowan AJ, Cole GO, Sather BD, Song X, Thomas S, Wood BL, Blake M, Works MG, Shadman M, Liang EC, Wu QV, Voutsinas JM, Gooley TA, Turtle CJ, Till BG, Coffey DG, Maloney DG, Riddell SR, Green DJ. A phase 1 trial of fully human BCMA CAR-T therapy for relapsed/refractory multiple myeloma with 5-year follow-up. Blood. 2025 Jul 31;146(5):535-545. doi: 10.1182/blood.2024027681. |
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3 patients withdrew consent after enrollment and did not move on to treatment. These 3 patients were not assigned to a dose level.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2020 |
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| Treatment (chemotherapy, BCMA CAR-T cells) at dose level 4 | Experimental | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) |
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| Cyclophosphamide | Drug | Given IV |
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| Fludarabine | Drug | Given IV |
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| Leukapheresis | Procedure | Undergo leukapheresis |
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| Baseline up to Day 28 |
| Objective Response Rate (ORR) | Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working group response criteria. | Baseline up to 3 months after CART infusion |
| Progression-free Survival (PFS) | Outcome is reported as the count of participants who were alive at the 1 year post treatment mark and did not experience disease progression by the 1 year post treatment mark. | Assessed up to 1 year after CART infusion |
| Overall Survival (OS) | Outcome is reported as a count of participants who were alive at the 1 year post-infusion timepoint. | Assessed up to 1 year after CART infusion |
| FG001 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| FG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| FG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| BG001 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| BG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| BG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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-limiting Toxicities (DLT) Rate | Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome will be reported as count of participants in each arm who experienced a DLT. No patients received more than one CAR T cell infusion, so DLT assessment period was only 28 days after first and only CAR T infusion for all patients. | Posted | Count of Participants | Participants | Up to 28 days after CAR T cell infusion |
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| Primary | Count of Patients That Experienced Adverse Events | Toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. | Posted | Count of Participants | Participants | Up to 28 days after CAR T-cell infusion |
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| Secondary | Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells | Persistence of CART cells is tested by qPCR in PBMC. | Posted | Median | Inter-Quartile Range | Days | Assessed from Baseline up to a maximum of 537 days |
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| Secondary | Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28 | CART cell migration to bone marrow was identified in all patients for whom a Day 28 bone marrow biopsy specimen was available (19 out of 19). In 6 cases, biopsy was not performed due to patient clinical status or bone marrow biopsy was attempted but no aspirate could be collected. | Posted | Count of Participants | Participants | Baseline up to Day 28 |
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| Secondary | Objective Response Rate (ORR) | Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working group response criteria. | Posted | Count of Participants | Participants | Baseline up to 3 months after CART infusion |
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| Secondary | Progression-free Survival (PFS) | Outcome is reported as the count of participants who were alive at the 1 year post treatment mark and did not experience disease progression by the 1 year post treatment mark. | Posted | Count of Participants | Participants | Assessed up to 1 year after CART infusion |
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| Secondary | Overall Survival (OS) | Outcome is reported as a count of participants who were alive at the 1 year post-infusion timepoint. | Posted | Count of Participants | Participants | Assessed up to 1 year after CART infusion |
|
Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year.
An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis | 4 | 7 | 5 | 7 | 7 | 7 |
| EG001 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis | 3 | 8 | 8 | 8 | 8 | 8 |
| EG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis | 0 | 7 | 5 | 7 | 7 | 7 |
| EG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis | 0 | 3 | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| NEUTROPENIC FEVER | Blood and lymphatic system disorders | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| FEVER | General disorders | Systematic Assessment |
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| CYTOKINE RELEASE SYNDROME | Immune system disorders | Systematic Assessment |
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| INFECTIONS AND INFESTATIONS - OTHER, LYSINIBACILLUS | Infections and infestations | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | Systematic Assessment |
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| UPPER RESPIRATORY INFECTION | Infections and infestations | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | Systematic Assessment |
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| FATIGUE | General disorders | Systematic Assessment |
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| FEVER | General disorders | Systematic Assessment |
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| PAIN | General disorders | Systematic Assessment |
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| PAIN NOS | General disorders | Systematic Assessment |
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| CYTOKINE RELEASE SYNDROME | Immune system disorders | Systematic Assessment |
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| INFECTIONS AND INFESTATIONS - OTHER, CMV | Infections and infestations | Systematic Assessment |
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| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY : BACTEREMIA | Infections and infestations | Systematic Assessment |
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| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Systematic Assessment |
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| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | Systematic Assessment |
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| ALANINE AMINOTRASFERASE INCREASED | Investigations | Systematic Assessment |
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| ALKALINE PHOSPHATASE INCREASED | Investigations | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | Systematic Assessment |
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| BILIRUBIN INCREASED | Investigations | Systematic Assessment |
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| CARDIAC TROPONIN INCREASED | Investigations | Systematic Assessment |
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| LYMPHOCYTE COUNT DECREASED | Investigations | Systematic Assessment |
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| LYMPHOCYTE COUNT DECREASED | Investigations | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASE | Investigations | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | Systematic Assessment |
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| PLATELET COUNT DECREASED | Investigations | Systematic Assessment |
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| PLATELET COUNT DECREASED | Investigations | Systematic Assessment |
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| WHITE BLOOD CELL DECREASED | Investigations | Systematic Assessment |
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| WHITE BLOOD CELL DECREASED | Investigations | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPERKALEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPERURICEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPOALBUMINEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPOCALCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOKALEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPONATREMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BONE PAIN (RIB) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HIP PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PAIN R HIP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| COGNITIVE DISTURBANCE | Nervous system disorders | Systematic Assessment |
| ||
| DYSPHASIA | Nervous system disorders | Systematic Assessment |
| ||
| ENCEPHALOPATHY | Nervous system disorders | Systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Systematic Assessment |
| ||
| MUSCLE WEAKNESS LEFT-SIDED | Nervous system disorders | Systematic Assessment |
| ||
| NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY - LEFT SIDE NEGLIGENCE | Nervous system disorders | Systematic Assessment |
| ||
| ANXIETY | Psychiatric disorders | Systematic Assessment |
| ||
| CONFUSION | Psychiatric disorders | Systematic Assessment |
| ||
| ACUTE KIDNEY INJURY | Renal and urinary disorders | Systematic Assessment |
| ||
| PROTEINURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| HYPERTENSION | Vascular disorders | Systematic Assessment |
| ||
| HYPOTENSION | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Damian Green | Fred Hutchinson Cancer Center | 2066675398 | dgreen@fredhutch.org |
| May 23, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007937 | Leukapheresis |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| OG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
|
|
| OG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| OG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
|
|
| OG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| OG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
|
|
| OG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| OG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
|
|
| OG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| OG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
|
|
| OG002 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
| OG003 | Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis |
|
|