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

Interventions

Locations Recruiting

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