Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma
NCT03380039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2020-10-12
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 -
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Siguo Hao, MD · Xin Hua Hospital of Shanghai Jiao Tong University of Medicine
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
- 2017-10-13
- Primary Completion
- 2020-07-02
- Completion
- 2023-07-02
Countries
- China
Study Locations
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