Actively Recruiting
Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma
Led by Sheba Medical Center · Updated on 2024-01-31
75
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, abbreviated (3+3) dose escalation study in subjects with RRMM, followed by an extension phase at the selected safe dose. The dose escalation stage will involve recruitment of 3 RRMM patients for 'low' dose (6 x 106 CAR-T cells/kg) CAR-T therapy. After 14 days of follow-up for each of the 3 subjects, the DSC will determine whether the next subject can be recruited. After 14 days follow-up for the 3rd subject, DSC will review data for the 3rd subject and consider the data for the first 3 subjects. In the absence of dose limiting toxicities (DLTs), the DSC may recommend recruitment of 3 subjects to be treated with the 'high' dose (9x106 CAR-T cells/kg) CAR-T therapy, with similar staggering. In case of DLTs in one of the 3 low dose subjects, the DSC may recommend to recruit an additional 3 low dose subjects (6 in total). If there are no additional DLTs in these 3 patients the low dose may be recommended by the DSC for the extension stage. However, further DLTs may prompt the DSC to recommend to modify the protocol, or to stop the study. In case of DLTs in one of the first 3 high dose subjects, the DSC may recommend to recruit an additional 3 high dose subjects.If there are no additional DLTs in these 3 patients, the high dose may be recommended by the DSC for the study extension stage. However, further DLTs may prompt the DSC to recommend continuation to the extension stage with the low dose, or to modify the protocol, or to stop the study. After completion of two months follow-up for the 6th subject in the low or high dose cohort (as applicable), and review of all the data for all subjects, following DSC recommendations, the Stage 2 extension phase of the study may recruit additional subjects, up to a maximum of 75 subjects for Stages 1 and 2, combined. DSC will review study data during the extension stage follow-up after 5 years to determine if additional safety follow-up is required.
CONDITIONS
Official Title
Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bone marrow plasma cells must be at least 10% of total bone marrow cells based on a biopsy or aspiration within 30 days before treatment start
- Confirmed diagnosis of multiple myeloma according to IMWG criteria
- Measurable multiple myeloma defined by at least one of the following: serum M-protein 0.4 g/dl, urine M-protein 200 mg/24 h, abnormal serum free light chain level 10 mg/dl with abnormal ratio, or biopsy-proven plasmacytoma
- At least 3 prior treatment regimens for multiple myeloma
- Age 18 years or older
- Able to understand and sign informed consent
- ECOG performance status of 0 to 2
- Willingness to practice birth control during the study and for 4 months after preparative regimen
- Negative pregnancy test for women of childbearing potential
- Seronegative for HIV-1 and HIV-2 antibodies
- Seronegative for hepatitis B surface antigen or positive with negative PCR for HBV nucleotides
- Seronegative for hepatitis C antibody or negative HCV RNA if antibody positive
- Negative for syphilis
- Absolute neutrophil count 500/mm3 without growth factors
- Platelet count 30,000/mm3 without transfusion support
- Hemoglobin greater than 8.0 g/dl
- Less than 5% plasma cells in peripheral blood leukocytes
- At least 14 days since prior systemic therapy with recovery to grade 1 or less toxicity
- No systemic anti-myeloma therapy or corticosteroids over 5 mg/day prednisone equivalent within 2 weeks before leukapheresis and CAR T-cell infusion, and no such therapy for 30 days after CAR T-cell infusion unless medically required
- Cardiac ejection fraction 45% by echocardiography within 6 weeks before treatment
You will not qualify if you...
- Second malignancies requiring treatment within the past 3 years, except treated non-metastatic basal or squamous cell skin cancer
- Pregnant or breastfeeding women
- Active systemic infections or major uncontrolled illnesses
- Active hepatitis B or C infection confirmed by positive PCR
- Systemic corticosteroid therapy over 5 mg/day prednisone equivalent within 2 weeks before leukapheresis or conditioning regimen
- Liver function tests with AST or ALT greater than 2.5 times upper limit of normal, or direct bilirubin greater than 2 times upper limit
- Renal function with creatinine clearance less than or equal to 20 ml/min
- History of severe allergic reaction to any study agents
- Central nervous system involvement
- Participation in another investigational study or use of investigational interventions within 15 days before leukapheresis except prior belantamab mafodotin use
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chaim Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel, 5262000
Actively Recruiting
Research Team
H
Hila Magen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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