CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms
NCT07416682 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-25
Summary
This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
Conditions
- High-risk Plasma Cell Neoplasms
Interventions
- GENETIC
-
CAR BCMA-CD70-T cells
Each subject will be infused with single dose of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10\^6 /kg, the medium dose is 2×10\^6 /kg, and the high dose is 3×10\^6 /kg.
- DRUG
-
fludarabine and cyclophosphamide
Description: Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells.
Sponsors & Collaborators
-
Affiliated Hospital to Academy of Military Medical Sciences
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2027-01-30
- Completion
- 2028-01-30
Countries
- China
Study Locations
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