A Phase 2 Study of Firi-cel in Patients with Relapsed/refractory Large B-cell Lymphoma
Purpose
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).
Conditions
- Cancer
- Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental Drug (Cohort 1) |
Single infusion of firi-cel following conditioning chemotherapy |
|
|
Experimental Experimental Drug (Cohort 2: non-conforming product) |
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 Experimental Drug (Cohort 3) |
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. |
|
Recruiting Locations
University of Arkansas Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
City of Hope National Medical Center
Duarte, California 91010
Duarte, California 91010
UCLA Division of Hematology Oncology
Los Angeles, California 90095
Los Angeles, California 90095
Stanford University Hospital and Clinics
Stanford, California 94305
Stanford, California 94305
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
University of Miami Hospital Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612-941
Tampa, Florida 33612-941
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
University of Iowa Hopitals & Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kansas Medical Center Research Institute, Inc
Westwood, Kansas 66205
Westwood, Kansas 66205
University of Maryland Medical Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
National Cancer Institute
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
Buffalo, New York 14263
New York University Medical Center
New York, New York 10016
New York, New York 10016
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
UT Southwestern Medical Center
Dallas, Texas 75390-9020
Dallas, Texas 75390-9020
Contact:
Yolanda Moore
214-645-9880
Yolanda Moore
214-645-9880
Swedish Medical Center
Seattle, Washington 98104
Seattle, Washington 98104
UW-Fred Hutchinson Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
Medical College of Wisconsin
Milwaukee, Wisconsin 53226-1222
Milwaukee, Wisconsin 53226-1222
More Details
- NCT ID
- NCT05972720
- Status
- Recruiting
- Sponsor
- CARGO Therapeutics
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.