OncoMatch/Clinical Trials/NCT05846737
BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT
Is NCT05846737 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies anti-BCMA CAR-T for multiple myeloma.
Treatment: anti-BCMA CAR-T — This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Disease stage
Required: Stage III, IV
Prior therapy
Must have received: induction therapy — first-line
Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT.
Must have received: autologous stem cell transplant — first-line
Has received...ASCT.
Cannot have received: maintenance therapy
Has received maintenance therapy.
Cannot have received: BCMA-targeted therapy
Prior exposure to any BCMA-targeted therapy
Cannot have received: CAR-T therapy
Prior exposure to...CAR-T therapy.
Lab requirements
Blood counts
WBC ≥ 1.5 x 10^9/L, ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L, PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%)
Kidney function
Creatinine clearance > 60mL/min (Cockroft-Gault formula)
Liver function
TBIL <1.5 x ULN (<3 x ULN in patients with Gilbert's syndrome); AST and ALT <3 x ULN
Screening laboratory values must meet the following criteria: a.TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT <3 x ULN.; c. Creatinine clearance > 60mL/min (calculated using the Cockroft-Gault formula). Routine blood tests...: WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 85 g/L PLT ≥ 75 x 109/L (if BMPC < 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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