A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
NCT05870917 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-02
Summary
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.
Conditions
- Plasma Cell Leukemia
Interventions
- BIOLOGICAL
-
anti-BCMA CAR-T
Autologous BCMA-directed CAR-T cells, the double infusion intravenously at a target dose of (2-4)±20% x 10\^6 anti-BCMA CAR+T cells/kg respectively
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-25
- Primary Completion
- 2026-06-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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