A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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.
EXCLUSION CRITERIA
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Cancer,Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Age
18+
Phase
PHASE2
Participants Needed
123
Est. Completion Date
Dec 13, 2026
Treatment Type
INTERVENTIONAL
Sponsor
CARGO Therapeutics
ClinicalTrials.gov NCT Identifier
NCT05972720
Study Number
CRG-022-101
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