OncoMatch/Clinical Trials/NCT05243212
Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma
Is NCT05243212 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CAR-BCMA for multiple myeloma.
Treatment: CAR-BCMA — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anti-myeloma therapy
Exception: at least 14 days must have elapsed since any prior systemic therapy at the time the subject starts the cyclophosphamide and fludarabine conditioning regimen, and subjects' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo)
At least 14 days must have elapsed since any prior systemic therapy at the time the subject starts the cyclophosphamide and fludarabine conditioning regimen, and subjects' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).
Cannot have received: systemic corticosteroid therapy (>5 mg/day prednisone or equivalent)
Exception: unless required for treatment of toxicity or other medical need
Systemic anti-myeloma therapy including systemic corticosteroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to the required leukapheresis, within 2 weeks prior to CAR T-cell infusion, and for 30 days after the CAR T cell infusion, unless required for treatment of toxicity or other medical need.
Cannot have received: systemic corticosteroid therapy (>5 mg/day prednisone or equivalent)
Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.
Cannot have received: investigational intervention or device
Exception: prior therapy with belantamab mafotodin can be used
Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 15 days prior to leukapheresis for CAR T-cell manufacture, or is currently enrolled in an investigational study. However, prior therapy with belantamab mafotodin can be used.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 500/mm3 without the support of filgrastim or other growth factors; Platelet count ≥ 30,000/mm3 without transfusion support; Hemoglobin > 8.0 g/dl
Kidney function
serum creatinine clearance /estimated clearance > 20 ml/min
Liver function
aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) and direct bilirubin ≤ 2 x ULN
Cardiac function
Cardiac ejection fraction ≥ 45% by echocardiography within 6 weeks of the start of the treatment protocol
Absolute neutrophil count ≥ 500/mm3 without the support of filgrastim or other growth factors. Platelet count ≥ 30,000/mm3 without transfusion support. Hemoglobin > 8.0 g/dl. Cardiac ejection fraction ≥ 45% by echocardiography within 6 weeks of the start of the treatment protocol. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) and direct bilirubin > 2 x ULN. Inadequate renal function defined by serum creatinine clearance /estimated clearance of ≤ 20(ml/min).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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