OncoMatch/Clinical Trials/NCT05979363
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Is NCT05979363 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including anti-BCMA CAR-T and VRD-based regimen for plasma cell leukemia.
Treatment: anti-BCMA CAR-T · VRD-based regimen — This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCMA (TNFRSF17) overexpression (BCMA-positive by flow cytometry or pathological examination)
Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BCMA-targeted therapy
Prior exposure to any BCMA-targeted therapy
Cannot have received: CAR-T cell therapy
Prior exposure to any ... CAR-T therapy
Lab requirements
Blood counts
WBC ≥ 1.5 x 10^9/L, ANC ≥ 1.0 x 10^9/L, Hb ≥ 70 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 ≥ 30mL/min (Cockroft-Gault formula)
Liver function
TBIL <2 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<2 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 ≥ 30mL/min (calculated using Cockroft-Gault formula). Routine blood tests ... : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 70 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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