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

• Status: Recruiting
• Trial end date: 2026-12-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CARGO Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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.