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

Sponsor: CARGO Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05972720

Patient View

This Phase 2 study evaluates firi-cel, a CD22-directed CAR T-cell therapy, in patients with R/R LBCL post-CD19 CAR T-cell therapy. Eligible participants are adults with confirmed LBCL, measurable lesions, and adequate organ function. Interventions include lymphodepletion with fludarabine and cyclophosphamide, followed by a single firi-cel infusion. Participants must stay near the treatment center for 4 weeks post-infusion.

Patient Parameters

Program Overview

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).

Description

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.

Eligibility Criteria

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.

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