Status:
TERMINATED
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
Lead Sponsor:
CARGO Therapeutics
Conditions:
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 autoleuc...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05972720
Start Date
August 1 2023
End Date
April 4 2025
Last Update
May 15 2025
Active Locations (31)
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1
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States, 72205
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
UCLA Division of Hematology Oncology
Los Angeles, California, United States, 90095
4
Stanford University Hospital and Clinics
Stanford, California, United States, 94305