Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients
NCT04935580 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-08-03
Summary
This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of GC012F in high-risk, transplant eligible patients with NDMM.
Conditions
Interventions
- BIOLOGICAL
-
GC012F injection
GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.
Sponsors & Collaborators
-
Gracell Biotechnologies (Shanghai) Co., Ltd.
collaborator INDUSTRY -
Shanghai Changzheng Hospital
lead OTHER
Principal Investigators
-
Juan Du, MD · Shanghai Changzheng Hospital
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
- 2021-06-28
- Primary Completion
- 2023-07-01
- Completion
- 2023-07-01
Countries
- China
Study Locations
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