Trials / Recruiting
RecruitingNCT06235229
A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma
A Phase I/II Clinical Study of Chimeric Antigen Receptor T-cell Therapy Targeting CD19 and BCMA (GC012F) in Patients With Relapsed/Refractory Multiple Myeloma
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a single-arm, open-lable, phase I/II study to evaluate the efficacy and safety of GC012F in subjects with relapsed/refractory multiple myeloma.
Detailed description
A leukapheresis procedure will be performed on eligible subjects to manufacture GC012F.Subjects will receive an infusion of GC012F at specified doses after three consecutive days of lymphodepletion consisting of fludarabine and cyclophosphamide. Bridging therapy is allowed between leukapheresis and lymphodepletion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GC012F | GC012F is a BCMA/CD19 dual CAR product |
Timeline
- Start date
- 2023-12-26
- Primary completion
- 2026-03-02
- Completion
- 2026-03-02
- First posted
- 2024-01-31
- Last updated
- 2026-02-25
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06235229. Inclusion in this directory is not an endorsement.