Overview
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.
Principal investigator
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.
* 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.
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