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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05972720
Other study ID # CRG-022-101
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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