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

a study on Cancer, General Lymphoma CAR T-Cell Therapy

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by John Timmerman

Description

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).

Official Title

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

Details

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.

Keywords

Cancer, Relapsed/Refractory Large B-cell Lymphoma (LBCL), Lymphoma, CD-22 Expressing Tumor, Chimeric Antigen Receptor, Adoptive Immunotherapy, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Primary Mediastinal B-cell, Lymphoma, Transformed, Lymphoma, Transformed Non-Hodgkin, Lymphoma, Non-Hodgkin, CAR T, CAR T-cell therapy, Cell Therapy, Cellular Immuno-therapy, CRG-022, CD22, FIRCE-1, firicabtagene autoleucel, firi-cel, B-Cell Lymphoma, Cyclophosphamide, Fludarabine, Fludarabine (Conditional therapy), Cyclophosphamide Monohydrate (Conditional therapy), firi-cel (Experimental drug)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA Division of Hematology Oncology accepting new patients
    Los Angeles California 90095 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCLA

  • John Timmerman
    Professor, Medicine. Authored (or co-authored) 75 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CARGO Therapeutics
ID
NCT05972720
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 123 study participants
Last Updated