drugset / Trial / NCT05641428
Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL
Phase 2
Recruiting
300 enrolled
University Medical Center Groningen
Stichting Hemato-Oncologie voor Volwassenen Nederland · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.
Timeline
- Start
- 2022-10-18
- Primary completion
- 2025-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARI-0001 | Cell therapy | 2e+06 cells/kg | — |
| Comparator | Axicabtagene Ciloleucel | Cell therapy | 2e+06 cells/kg | — |