Trial Title:
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
NCT ID:
NCT05972720
Condition:
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Conditions: Keywords:
Lymphoma
CD-22 Expressing Tumor
Chimeric Antigen Receptor
Adoptive Immunotherapy
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Primary Mediastinal B-cell
Lymphoma, Transformed
Lymphoma, Transformed Non-Hodgkin
Lymphoma, Non-Hodgkin
CAR T
CAR T-cell therapy
Cell Therapy
Cellular Immuno-therapy
CRG-022
CD22
FIRCE-1
firicabtagene autoleucel
firi-cel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fludarabine (Conditional therapy)
Description:
Lymphodepletion chemotherapy
Arm group label:
Experimental Drug (Cohort 1)
Arm group label:
Experimental Drug (Cohort 2: non-conforming product)
Arm group label:
Experimental Drug (Cohort 3)
Intervention type:
Drug
Intervention name:
Cyclophosphamide Monohydrate (Conditional therapy)
Description:
Lymphodepletion chemotherapy
Arm group label:
Experimental Drug (Cohort 1)
Arm group label:
Experimental Drug (Cohort 2: non-conforming product)
Arm group label:
Experimental Drug (Cohort 3)
Intervention type:
Drug
Intervention name:
firi-cel (Experimental drug)
Description:
Investigational agent
Arm group label:
Experimental Drug (Cohort 1)
Arm group label:
Experimental Drug (Cohort 2: non-conforming product)
Arm group label:
Experimental Drug (Cohort 3)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Carter
Phone:
501-686-8274
Email:
JBCarter@uams.edu
Contact backup:
Last name:
Holly Jarrel
Phone:
501-686-8274
Email:
HRJarrel@uams.edu
Investigator:
Last name:
Cesar Gentille Sanchez, M.D.
Email:
Principal Investigator
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rocki Williams
Email:
raqwilliams@coh.org
Contact backup:
Last name:
Kim Cornejo
Email:
kcornejoperil@coh.org
Investigator:
Last name:
John Baird
Email:
Principal Investigator
Facility:
Name:
UCLA Division of Hematology Oncology
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chris Hannigan
Phone:
310-825-4493
Email:
CHannigan@mednet.ucla.edu
Investigator:
Last name:
John Timmerman
Email:
Principal Investigator
Facility:
Name:
Stanford University Hospital and Clinics
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephanie Rodriguez
Phone:
650-721-8580
Email:
starz@stanford.edu
Contact backup:
Last name:
Kendall Levine
Phone:
(650)498-1328
Email:
klevine@stanford.edu
Investigator:
Last name:
Matthew Frank
Email:
Principal Investigator
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Autumn Warner
Phone:
720-754-8071
Email:
Autumn.Warner@SarahCannon.com
Contact backup:
Last name:
Ben Burtness
Phone:
720.754.8064
Email:
Ben.Burtness@sarahcannon.com
Investigator:
Last name:
Michael Tees
Email:
Principal Investigator
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clara Wong
Phone:
203-641-9464
Email:
clara.wong@yale.edu
Investigator:
Last name:
Iris Isufi, M.D.
Email:
Principal Investigator
Facility:
Name:
University of Miami Hospital Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Keerthi Paladugu
Phone:
305-243-9590
Email:
kxp947@miami.edu
Investigator:
Last name:
Jay Spiegel, MD
Email:
Principal Investigator
Facility:
Name:
H. Lee Moffitt Cancer Center and Research Institute
Address:
City:
Tampa
Zip:
33612-941
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kesley Lee
Phone:
813-745-8228
Email:
kelsey.lee@moffitt.org
Investigator:
Last name:
Michael Jain, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adriane Strong
Phone:
404-851-6908
Email:
Adriane.Strong@northside.com
Contact backup:
Last name:
Kirkland Armstrong
Email:
Kirkland.Armstrong@northside.com
Investigator:
Last name:
Lizamarie Bachier-Rodriguez, M.D.
Email:
Principal Investigator
Facility:
Name:
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chiena Whitt
Phone:
312-695-2084
Email:
chiena.whitt@northwestern.edu
Investigator:
Last name:
Reem Karmali, MD
Email:
Principal Investigator
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Gilson
Phone:
773-834-9517
Email:
andrew.gilson@bsd.uchicago.edu
Contact backup:
Last name:
Anto Jean Xavior
Phone:
773-834-9316
Email:
antojean.xavior@bsd.uchicago.edu
Investigator:
Last name:
Peter Riedell, MD
Email:
Principal Investigator
Facility:
Name:
University of Iowa Hopitals & Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michele Pegg
Email:
michele-pegg@uiowa.edu
Contact backup:
Last name:
Erin Frimml
Email:
erin-frimml@uiowa.edu
Investigator:
Last name:
Farooq, Umar
Email:
Principal Investigator
Facility:
Name:
University of Kansas Medical Center Research Institute, Inc
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
C Stockard
Phone:
913-588-0512
Email:
cstockard@kumc.edu
Contact backup:
Last name:
M Youngberg
Phone:
913-588-7585
Email:
myoungberg@kumc.edu
Investigator:
Last name:
Joseph McGuirk
Email:
Principal Investigator
Facility:
Name:
University of Maryland Medical Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colleen Marie Meegan
Phone:
410-328-7339
Email:
cmeegan@umm.edu
Investigator:
Last name:
Jean Yared, MD
Email:
Principal Investigator
Facility:
Name:
National Cancer Institute
Address:
City:
Bethesda
Zip:
20892
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bonnie Yates
Phone:
240-760-6204
Email:
bonnie.yates@nih.gov
Investigator:
Last name:
Nirali Shah, MD, MHSc
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hailie Hale
Phone:
617-975-7426
Email:
hhale@bidmc.harvard.edu
Contact backup:
Last name:
Lillian Needam
Phone:
617-975-7466
Email:
lneedam@bidmc.harvard.edu
Investigator:
Last name:
Jon Arnason, M.D.
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Meehan
Phone:
617-582-7106
Email:
ChristopherJ_Meehan@DFCI.HARVARD.EDU
Investigator:
Last name:
Caron Jacobson
Email:
Principal Investigator
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sabrina Hargrove
Email:
sgomes@med.umich.edu
Investigator:
Last name:
Monalisa Ghosh, MD
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Whitney Anderson
Phone:
314-273-4903
Email:
whitney.anderson@wustl.edu
Investigator:
Last name:
Armin Ghobadi
Email:
Principal Investigator
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Janine Miller
Phone:
716-845-8982
Email:
Janine.Miller@RoswellPark.org
Contact backup:
Last name:
Chris Suchan
Phone:
(716) 845-6283
Email:
Christopher.Suchan@RoswellPark.org
Investigator:
Last name:
Francisco Hernandez-Ilizaliturri
Email:
Principal Investigator
Facility:
Name:
New York University Medical Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gianna Insogna
Email:
Gianna.Insogna@nyulangone.org
Contact backup:
Last name:
Antoine Mesidor
Phone:
212-263-4403
Email:
Antoine.Mesidor@nyulangone.org
Investigator:
Last name:
Catherine Diefenbach
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Briana Long
Phone:
216-636-8655
Email:
longb@ccf.org
Investigator:
Last name:
Craig Sauter
Email:
Principal Investigator
Facility:
Name:
The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thomas Needham
Phone:
614-293-7934
Email:
Thomas.Needham@osumc.edu
Investigator:
Last name:
Nathan Denlinger, DO
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jaldhi Patel
Phone:
215-898-8505
Email:
Jaldhi.Patel@pennmedicine.upenn.edu
Contact backup:
Last name:
Allison Nelson
Phone:
215-908-1249
Email:
Allison.Nelson@pennmedicine.upenn.edu
Investigator:
Last name:
Elise Chong, MD
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Henry
Email:
Megan.Henry2@jefferson.edu
Investigator:
Last name:
Usama Gergis, MD, MBA
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rohan Goel
Phone:
615-936-2647
Email:
rohan.w.goel@vumc.org
Investigator:
Last name:
Olalekan Oluwole, MD
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-9020
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yolanda Moore
Phone:
214-645-9880
Contact backup:
Last name:
Maria Raju
Phone:
468-894-7256
Investigator:
Last name:
Farrukh Awan, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swapna Binoy
Email:
SJBinoy@mdanderson.org
Contact backup:
Last name:
Sattva Neelapu
Facility:
Name:
Swedish Medical Center
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Dodson
Phone:
206-386-6776
Email:
andrew.d.dodson@swedish.org
Contact backup:
Last name:
Tori Braun
Phone:
206-386-6776
Email:
tori.braun@swedish.org
Investigator:
Last name:
Krish Patel, MD
Email:
Principal Investigator
Facility:
Name:
UW-Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alisa Bradford
Phone:
206-667-2834
Email:
ajbradfo@fredhutch.org
Contact backup:
Last name:
David Qian
Phone:
206-667-3787
Email:
dqian@fredhutch.org
Investigator:
Last name:
Jordan Gauthier, MD, MSc
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226-1222
Country:
United States
Status:
Recruiting
Contact:
Last name:
Haily McArthey
Phone:
414-805-8931
Email:
hmcarthey@mcw.edu
Contact backup:
Last name:
Roisin McAndrew
Phone:
414-805-4557
Email:
rmcandrew@mcw.edu
Investigator:
Last name:
Nirav Shah, MD
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
December 13, 2026
Lead sponsor:
Agency:
CARGO Therapeutics
Agency class:
Industry
Source:
CARGO Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05972720
