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 (Jun 2026). This Phase 2 trial studies anti-BCMA CAR-T for plasma cell leukemia.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Multiple Myeloma
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05870917 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require TNFRSF17?
Yes, TNFRSF17 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages