Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
NCT07250269 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-04-28
Summary
This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.
Conditions
- Relapsed/Refractory AL Amyloidosis
Interventions
- DRUG
-
GC012F Injection
The investigational agent, GC012F, is an autologous BCMA/CD19 dual directed CAR product under investigation for the treatment of patients with RRMM, ELMM, SLE, and B NHL.
Sponsors & Collaborators
-
Suzhou Gracell Biotechnologies Co., Ltd.
collaborator UNKNOWN -
Gracell Biotechnologies (Shanghai) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-29
- Primary Completion
- 2028-11-24
- Completion
- 2028-11-24
Countries
- China
Study Locations
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