A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma

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

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.

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.