Phase 12 Study of EBNK-001 Allogeneic NK Cell Therapy with Low-Dose IL-15, with or without Pembrolizumab, for Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early anti-tumor effects of EBNK-001, an off-the-shelf allogeneic natural killer NK cell therapy, given with low-dose interleukin-15. This Phase 12 study includes adults with advanced or metastatic solid tumors that have returned or not responded to standard treatments. The trial aims to find the best dose for further study and assess tumor responses using established criteria. Participants first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine to help the NK cells expand and last longer. Then, they get weekly infusions of EBNK-001 on Days 1, 8, and 15 of each treatment cycle, supported by low-dose IL-15 after each infusion. The study has two parts Phase 1 tests increasing doses to identify the maximum tolerated dose and recommended dose for Phase 2, while Phase 2 focuses on preliminary effectiveness in selected tumor types. Some participants may also receive pembrolizumab alongside the NK cell therapy. During the study, participants are monitored for tumor response until their disease progresses and followed for survival for at least 12 months. Researchers track side effects and serious adverse events closely, especially in the first 30 days after the first NK cell infusion. If EBNK-001 is considered gene-modified, participants might join a long-term follow-up study to monitor safety. The overall participation duration depends on individual response and treatment continuation.

EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors