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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.

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT05979363Data as of May 2026

Treatment: anti-BCMA CAR-T · VRD-based regimenThis 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

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Extracted 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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