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An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Firi-cel, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy


Description

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).Firicabtagene autoleucel (firi-cel) is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of firi-cel.

Trial Eligibility

Key Inclusion Criteria: * Aged ≥18 years * Relapsed or refractory, histologically confirmed large B-cell lymphoma. * Must have relapsed or refractory diseae after last therapy. * For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy * For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy. * Must have at least one radiographically measurable lesion. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematological, renal, and liver function * Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion. Key Exclusion Criteria: * Clinically significant concurrent medical illness * Active fungal, bacterial, viral or other infection. * Prior allogeneic stem cell transplant or allogeneic cell therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Info

Organization

CARGO Therapeutics


Primary Outcome

Objective response rate - Blinded independent review


Outcome Timeframe Up to 24 months

NCTID NCT05972720

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2023-08-01

Completion Date 2025-09-13

Enrollment Target 123

Interventions

DRUG Fludarabine (Conditional therapy)

DRUG Cyclophosphamide Monohydrate (Conditional therapy)

DRUG firi-cel (Experimental drug)

Locations Recruiting

University of Arkansas Medical Sciences

United States, Arkansas, Little Rock


City of Hope National Medical Center

United States, California, Duarte


UCLA Division of Hematology Oncology

United States, California, Los Angeles


Stanford University Hospital and Clinics

United States, California, Stanford


Colorado Blood Cancer Institute

United States, Colorado, Denver


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