Clinical trial · Interventional
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision to stop trial, withdraw the IND and close down operations.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Relapsed/Refractory Large B-cell Lymphoma (LBCL) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide Monohydrate (Conditional therapy) | Drug | Cyclophosphamide | ALIAS |
| firi-cel (Experimental drug) | Drug | — | UNRESOLVED |
| Fludarabine (Conditional therapy) | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Experimental Drug (Cohort 1)
- description
- Single infusion of firi-cel following conditioning chemotherapy
- interventionNames
- Drug: Fludarabine (Conditional therapy)
- Drug: Cyclophosphamide Monohydrate (Conditional therapy)
- Drug: firi-cel (Experimental drug)
- type
- EXPERIMENTAL
- label
- Experimental Drug (Cohort 2: non-conforming product)
- description
- Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).
- interventionNames
- Drug: Fludarabine (Conditional therapy)
- Drug: Cyclophosphamide Monohydrate (Conditional therapy)
- Drug: firi-cel (Experimental drug)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available