A Single-arm, Multicenter Study of Automated Axicabtagene Ciloleucel for R/R Large B-cell Lymphoma.
NCT07606937 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-05-26
Summary
This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r/r LBCL) as second-line therapy.
Conditions
- Relapsed/Refractory Large B-cell Lymphoma
Interventions
- DRUG
-
FKC876 injection
CD19 CAR-T
Sponsors & Collaborators
-
Shenzhen Fosun Kairos Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Wen Shi · FosunKarios
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2026-11-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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