Open
Actively Recruiting
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
About
Brief 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).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
23-000892
Category
Other Cancer
Principal Investigator
Contact
Location
- UCLA Westwood