Phase II Study Comparing Locally Made ARI-0001 CAR T-cells to Commercial CAR T-cells in Adults with Relapsed or Refractory Diffuse Large B Cell Lymphoma

What this Trial Is About

Researchers are comparing the feasibility and clinical effectiveness of locally made CD19-directed CAR T-cells called ARI-0001 with commercially produced CAR T-cells, such as axicabtagene ciloleucel, in patients with relapsed or refractory Diffuse Large B-cell Lymphoma DLBCL. This phase II study focuses on improving treatment accessibility and quality by addressing delays and quality issues caused by centralized production and cryopreservation in current therapies. The study involves two treatment groups one receiving ARI-0001 CAR T-cells produced on-site using the CliniMACS Prodigy device, which takes about 7-12 days and infuses fresh cells without cryopreservation the other receives standard commercial CAR T-cells like axicabtagene ciloleucel, which require longer production times and cryopreservation. Both treatments use a single target dose of approximately 2.0 x 106 CAR T-cells per kilogram of body weight. Participants will be closely monitored for up to 60 months after infusion, with assessments including progression-free survival, overall response rate, CAR T-cell expansion and persistence, adverse events, and quality of life measures. Various laboratory tests and patient questionnaires will be conducted at multiple time points up to two years post-infusion. The study aims to evaluate the clinical outcomes, safety, and production quality of the two CAR T-cell therapies over a long follow-up period.

Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL