A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT05972720
Trial Phases:	Phase II	Protocol IDs:	CRG-022-101 (primary) NCI-2023-06284
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	CARGO Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05972720

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).

Objectives

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.

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