Phase 2 Study of Firi-cel for Patients with Relapsed or Hard-to-Treat Large B-cell Lymphoma

Sponsor: CARGO Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05972720

Provider View

This clinical trial is testing a new treatment called firi-cel, a type of CAR T-cell therapy, to see if it is safe and effective for patients with large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of firicabtagene autoleucel (firi-cel), a CAR T-cell therapy targeting CD22, in patients with large B-cell lymphoma (LBCL) that has come back or not responded to treatment. Up to 123 patients will receive a single infusion of firi-cel to see how well it works and how safe it is.

Description

Firicabtagene autoleucel, or firi-cel, is a specialized treatment that uses a patient's own immune cells, modified to target a protein called CD22 found on B-cells, which are part of the immune system. This Phase 2 study is focused on patients whose large B-cell lymphoma (LBCL) has returned or not responded after previous treatments, including those who have already tried a similar therapy targeting CD19. The study will involve up to 123 patients who will receive one dose of firi-cel to assess its safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have large B-cell lymphoma that has returned or not responded to treatment.
  • Must have tried previous treatments that did not work.
  • For some groups, must have previously received a CD19-directed CAR T-cell therapy.
  • For other groups, must have had at least two prior treatments, including a specific antibody therapy.
  • Must have at least one tumor that can be measured by scans.
  • Must be in good general health, able to perform daily activities with little or no assistance.
  • Must have good blood, kidney, and liver function.
  • Must be willing to stay within an hour's travel of the treatment center for at least four weeks after receiving the treatment.

Exclusion Criteria

  • Have a serious medical condition that could interfere with the study.
  • Have an active infection, such as fungal, bacterial, or viral.
  • Have had a previous stem cell transplant from a donor or other cell therapy from a donor.

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