Study Stopped
Company decision to stop trial, withdraw the IND and close down operations.
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
FIRCE-1
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
1 other identifier
interventional
101
1 country
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Aug 2023
Shorter than P25 for phase_2 cancer
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2025
CompletedMay 15, 2025
May 1, 2025
1.7 years
July 25, 2023
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Objective response rate - Investigator assessment
Up to 24-months
Complete response rate
Up to 24-months
Duration of response
Up to 24-months
Duration of complete response
Up to 24-months
Progression-free survival
Up to 24-months
- +2 more secondary outcomes
Study Arms (3)
Experimental Drug (Cohort 1)
EXPERIMENTALSingle infusion of firi-cel following conditioning chemotherapy
Experimental Drug (Cohort 2: non-conforming product)
EXPERIMENTALSingle 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)
EXPERIMENTALPatients 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.
Interventions
Lymphodepletion chemotherapy
Lymphodepletion chemotherapy
Investigational agent
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Clinically significant concurrent medical illness
- Active fungal, bacterial, viral or other infection.
- Prior allogeneic stem cell transplant or allogeneic cell therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
UCLA Division of Hematology Oncology
Los Angeles, California, 90095, United States
Stanford University Hospital and Clinics
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Yale University
New Haven, Connecticut, 06511, United States
University of Miami Hospital Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-941, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Iowa Hopitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center Research Institute, Inc
Westwood, Kansas, 66205, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
National Cancer Institute
Bethesda, Maryland, 20892, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
New York University Medical Center
New York, New York, 10016, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9020, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
UW-Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
August 1, 2023
Primary Completion
April 4, 2025
Study Completion
April 4, 2025
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share