A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma (FIRCE-1)

CARGO Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Relapsed/Refractory Large B-cell Lymphoma (LBCL); Cancer

Treatments: Drug: Fludarabine (Conditional therapy); Drug: firi-cel (Experimental drug); Drug: Cyclophosphamide Monohydrate (Conditional therapy)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05972720

CRG-022-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 123 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 3 patient groups

Experimental Drug (Cohort 1)

Experimental group

Description:

Single infusion of firi-cel following conditioning chemotherapy

Treatment:

Drug: firi-cel (Experimental drug)

Drug: Cyclophosphamide Monohydrate (Conditional therapy)

Drug: Fludarabine (Conditional therapy)

Experimental Drug (Cohort 2: non-conforming product)

Experimental group

Description:

Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).

Treatment:

Drug: firi-cel (Experimental drug)

Drug: Cyclophosphamide Monohydrate (Conditional therapy)

Drug: Fludarabine (Conditional therapy)

Experimental Drug (Cohort 3)

Experimental group

Description:

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.

Treatment:

Drug: firi-cel (Experimental drug)

Drug: Cyclophosphamide Monohydrate (Conditional therapy)

Drug: Fludarabine (Conditional therapy)