A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
NCT05972720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2025-05-15
Summary
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).
Conditions
- Cancer
- Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Interventions
- DRUG
-
Fludarabine (Conditional therapy)
Lymphodepletion chemotherapy
- DRUG
-
Cyclophosphamide Monohydrate (Conditional therapy)
Lymphodepletion chemotherapy
- DRUG
-
firi-cel (Experimental drug)
Investigational agent
Sponsors & Collaborators
-
CARGO Therapeutics
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
- 2023-08-01
- Primary Completion
- 2025-04-04
- Completion
- 2025-04-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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