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A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
Trial Status: administratively complete
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).
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05972720.
