A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
CRG-022-101 (primary)
NCI-2023-06284
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.
Eligibility
- 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
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
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