Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma
NCT03716856 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2020-10-08
Summary
A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.
Conditions
- Refractory or Relapsed Multiple Myeloma
Interventions
- GENETIC
-
CAR-BCMA T cells
Single dose of CAR-BCMA T cells will be infused, and classic "3+3" dose escalation will be applied.
- DRUG
-
Fludarabine is used for lymphodepletion.
- DRUG
-
Cyclophosphamide is used for lymphodepletion
Sponsors & Collaborators
-
CARsgen Therapeutics Co., Ltd.
collaborator INDUSTRY -
First Affiliated Hospital of Zhejiang University
lead OTHER
Principal Investigators
-
Jie Jin, MD · First Affiliated Hospital of Zhejiang University
-
Haitao Meng, MD · First Affiliated Hospital of Zhejiang University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-23
- Primary Completion
- 2020-06-23
- Completion
- 2023-06-23
Countries
- China
Study Locations
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