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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
Interventions
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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