Phase 12 Study of Engineered Dual-Target CSPG4GD2 CAR-NK Cell Therapy for Adults With Advanced or Metastatic Cutaneous or Uveal Melanoma

What this Trial Is About

Researchers are evaluating the safety, feasibility, recommended dose for phase 2, and early anti-cancer effects of allogeneic dual-target CSPG4GD2 CAR-NK cells called EB-DTKN-401 in adults with advanced unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard treatments. This open-label, multicenter phase 12 study focuses on patients with tumors expressing CSPG4 andor GD2, aiming to improve treatment options for these challenging melanoma types. The study includes three groups a dose-escalation safety lead-in phase to find the recommended phase 2 dose, followed by expansion cohorts for cutaneous and uveal melanoma. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, then receive one to three infusions of EB-DTKN-401 over 15 days at varying dose levels. The CAR-NK cells are immune cells engineered to target two melanoma-associated proteins, aiming to enhance tumor killing and reduce immune escape. During the trial, participants will be closely monitored for dose-limiting toxicities and treatment side effects up to 12 months. Researchers will assess tumor response, disease control, duration of response, progression-free survival, overall survival, and persistence of CAR-NK cells over up to 24 months. Visits include clinical evaluations, imaging to measure tumors, blood tests, and biopsies. The total study duration varies by participant but includes safety assessments and long-term follow-up to evaluate treatment impact and patient outcomes.

Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma