Phase 12 Study of ST-067 with CD19-Targeted CAR T-Cell Therapy Liso-cel for Adults with Relapsed or Refractory Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety, side effects, and optimal dosing of ST-067 combined with CD19-directed CAR T-cell therapy liso-cel in patients with large B-cell lymphoma LBCL that has returned after improvement or has not responded to previous treatments. This phase III trial explores whether adding ST-067, an engineered interleukin-18 variant, to liso-cel, a personalized immune cell therapy, may improve treatment outcomes for relapsed or refractory LBCL. Participants undergo leukapheresis and lymphodepleting chemotherapy shortly before receiving liso-cel intravenously on day 0. Following this, patients receive ST-067 subcutaneously on specified weekly days, with the possibility of continued maintenance dosing up to eight doses unless disease progresses or unacceptable side effects occur. The study includes detailed imaging and laboratory procedures, including x-rays, PETCT scans, echocardiography or MUGA scans, lumbar puncture, bone marrow biopsy, and blood sampling throughout treatment and follow-up. During the study, participants are monitored with scans and clinical assessments to evaluate safety, response rates, and other outcomes up to four years. Follow-up visits occur at 3, 6, 9, and 12 months post-infusion, then continue per standard care for long-term monitoring. Researchers measure adverse events, dose-limiting toxicities, response rates, survival, and other efficacy markers to assess the combination therapys effects in treating LBCL.

ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma