A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
Trial ID or NCT#
Status
Purpose
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).
Official Title
An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Firi-cel, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy
Eligibility 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
- * 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Kelly Chyan
650-625-8130
View on ClinicalTrials.gov