A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
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).
Conditions
- Cancer
- Relapsed/Refractory Large B-cell Lymphoma (LBCL)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental Drug (Cohort 1) |
Single infusion of firi-cel following conditioning chemotherapy |
|
|
Experimental Experimental Drug (Cohort 2: non-conforming product) |
Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer). |
|
|
Experimental Experimental Drug (Cohort 3) |
Patients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy. |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- CARGO Therapeutics
Detailed Description
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.