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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Lymphodepletion chemotherapy
Lymphodepletion chemotherapy
Investigational agent
Objective response rate - Blinded independent review
Percentage of patients with complete or partial response determined by a blinded independent review committee
Time frame: Up to 24 months
Objective response rate - Investigator assessment
Percentage of patients with complete or partial response determined by the investigator
Time frame: Up to 24-months
Complete response rate
Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment
Time frame: Up to 24-months
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
Time frame: Up to 24-months
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.
Time frame: Up to 24-months
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
Time frame: Up to 24-months
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.
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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
...and 21 more locations
Time frame: Up to 24-months
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.
Time frame: From Screening up to 15 years at protocol-defined timepoints