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

Cancer Clinical Trial

— FIRCE-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972720
• Other study ID #: CRG-022-101
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: December 13, 2026

Study information

• Verified date: June 2024
• Source: CARGO Therapeutics
• Contact: CargoTx Email address
• Phone: (650) 499-8952
• Email: clinicaltrials[@]cargo-tx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: December 13, 2026
• Est. primary completion date: September 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• Fludarabine (Conditional therapy)
Lymphodepletion chemotherapy
• Cyclophosphamide Monohydrate (Conditional therapy)
Lymphodepletion chemotherapy
• firi-cel (Experimental drug)
Investigational agent

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan
United States	Northside Hospital	Atlanta	Georgia
United States	National Cancer Institute	Bethesda	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	City of Hope National Medical Center	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa Hopitals & Clinics	Iowa City	Iowa
United States	University of Arkansas Medical Sciences	Little Rock	Arkansas
United States	UCLA Division of Hematology Oncology	Los Angeles	California
United States	University of Miami Hospital Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	New York University Medical Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington
United States	UW-Fred Hutchinson Cancer Center	Seattle	Washington
United States	Stanford University Hospital and Clinics	Stanford	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	University of Kansas Medical Center Research Institute, Inc	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
CARGO Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate - Blinded independent review	Percentage of patients with complete or partial response determined by a blinded independent review committee	Up to 24 months
Secondary	Objective response rate - Investigator assessment	Percentage of patients with complete or partial response determined by the investigator	Up to 24-months
Secondary	Complete response rate	Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment	Up to 24-months
Secondary	Duration of response	Duration of response (the time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators	Up to 24-months
Secondary	Duration of complete response	Time from the date of the first occurrence of CR to the date of progression, relapse, or death from any cause determined by independent review committee and investigators.	Up to 24-months
Secondary	Progression-free survival	Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment	Up to 24-months
Secondary	Overall Survival	Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the Investigator.	Up to 24-months
Secondary	Incidence rate of adverse events	Percentage of patients with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.	From Screening up to 15 years at protocol-defined timepoints