Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
NCT03455972 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-03-17
Summary
CART therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.
Conditions
- Safety and Efficacy
Interventions
- BIOLOGICAL
-
anti-CD19 and anti-BCMA CAR
Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (1×10e+7/kg on d0) and anti-BCMA CAR T cells as split-dose (total 5×10e+7/kg, 40% on d1 and 60% on d2)
- DRUG
-
Immunomodulatory drugs
Maintenance therapy
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
depei wu · The First Affiliated Hospital of Soochow University
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
- 2018-02-20
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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