A Phase 2 Study of Firi-cel in Patients with Relapsed/refractory Large B-cell Lymphoma
- Conditions
- CancerRelapsed/Refractory Large B-cell Lymphoma (LBCL)
- Interventions
- Drug: Fludarabine (Conditional therapy)Drug: Cyclophosphamide Monohydrate (Conditional therapy)Drug: firi-cel (Experimental drug)
- Registration Number
- NCT05972720
- Lead Sponsor
- CARGO Therapeutics
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 123
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Drug (Cohort 1) Cyclophosphamide Monohydrate (Conditional therapy) Single infusion of firi-cel following conditioning chemotherapy Experimental Drug (Cohort 2: non-conforming product) Cyclophosphamide Monohydrate (Conditional therapy) Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer). Experimental Drug (Cohort 3) Cyclophosphamide Monohydrate (Conditional therapy) 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. Experimental Drug (Cohort 1) Fludarabine (Conditional therapy) Single infusion of firi-cel following conditioning chemotherapy Experimental Drug (Cohort 1) firi-cel (Experimental drug) Single infusion of firi-cel following conditioning chemotherapy Experimental Drug (Cohort 2: non-conforming product) Fludarabine (Conditional therapy) Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer). Experimental Drug (Cohort 2: non-conforming product) firi-cel (Experimental drug) Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer). Experimental Drug (Cohort 3) Fludarabine (Conditional therapy) 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. Experimental Drug (Cohort 3) firi-cel (Experimental drug) 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.
- Primary Outcome Measures
Name Time Method Objective response rate - Blinded independent review Up to 24 months Percentage of patients with complete or partial response determined by a blinded independent review committee
- Secondary Outcome Measures
Name Time Method Duration of response Up to 24-months 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
Progression-free survival Up to 24-months 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
Objective response rate - Investigator assessment Up to 24-months Percentage of patients with complete or partial response determined by the investigator
Complete response rate Up to 24-months Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment
Duration of complete response Up to 24-months 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.
Incidence rate of adverse events From Screening up to 15 years at protocol-defined timepoints Percentage of patients with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.
Overall Survival Up to 24-months Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the Investigator.
Trial Locations
- Locations (31)
University of Arkansas Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
UCLA Division of Hematology Oncology
🇺🇸Los Angeles, California, United States
Stanford University Hospital and Clinics
🇺🇸Stanford, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Miami Hospital Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Iowa Hopitals & Clinics
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center Research Institute, Inc
🇺🇸Westwood, Kansas, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, 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
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
New York University Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
UW-Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States