OncoMatch/Clinical Trials/NCT05870917

A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia

Is NCT05870917 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies anti-BCMA CAR-T for plasma cell leukemia.

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT05870917Data as of May 2026

Treatment: anti-BCMA CAR-T — This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed 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

No prior treatment (treatment-naive required)

Max 0 prior lines

Lab requirements

Blood counts

ANC ≥ 1.0 x 10^9/L, PLT ≥ 50 x 10^9/L

Kidney function

Creatinine clearance ≥ 50mL/min (Cockroft-Gault formula)

Liver function

Total bilirubin <1.5 x upper limit of normal (ULN); ALT and AST

Cardiac function

LVEF ≥ 50% on echocardiography; no unstable angina, symptomatic myocardial ischaemia, MI or coronary artery reconstruction within 180 days; no uncontrolled hypertension (>140/90 mmHg with BP fluctuations >180/100 mmHg over 6 months); no uncontrolled and clinically significant conduction abnormalities (except 1st degree AV block or asymptomatic LAFB/RBBB); no CHF ≥ grade 3 (NYHA); no history of stroke or intracranial haemorrhage within 12 months; no serious thrombotic event prior to treatment.

Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days): ANC ≥ 1.0 x 10^9/L, PLT ≥ 50 x 10^9/L. All screening blood biochemistry: Total bilirubin <1.5 x ULN; ALT and AST; Creatinine clearance ≥ 50mL/min. Cardiac: see exclusion criteria for details.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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