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

Purpose

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).

Conditions

  • Cancer
  • Relapsed/Refractory Large B-cell Lymphoma (LBCL)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental Drug (Cohort 1) 		Single infusion of firi-cel following conditioning chemotherapy
  • Drug: Fludarabine (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: Cyclophosphamide Monohydrate (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: firi-cel (Experimental drug)
    Investigational agent
Experimental
Experimental Drug (Cohort 2: non-conforming product) 		Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).
  • Drug: Fludarabine (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: Cyclophosphamide Monohydrate (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: firi-cel (Experimental drug)
    Investigational agent
Experimental
Experimental Drug (Cohort 3) 		Patients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy.
  • Drug: Fludarabine (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: Cyclophosphamide Monohydrate (Conditional therapy)
    Lymphodepletion chemotherapy
  • Drug: firi-cel (Experimental drug)
    Investigational agent

Recruiting Locations

University of Kansas Medical Center Research Institute, Inc
Westwood, Kansas 66205
Contact:
C Stockard
913-588-0512
cstockard@kumc.edu

More Details

Status
Recruiting
Sponsor
CARGO Therapeutics

Study Contact

CargoTx Email address
(650) 499-8952
clinicaltrials@cargo-tx.com

Detailed 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.