Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma
Sponsor: Beijing Biotech
Summary
This is a first-in-human, open-label, multicenter phase 1/2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4/GD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard therapy
Official title: An Open-Label, Multicenter Phase 1/2 Study of Allogeneic Dual-Target CSPG4/GD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous Melanoma or Metastatic Uveal Melanoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-03-02
Completion Date
2028-06-17
Last Updated
2026-06-04
Healthy Volunteers
No
Interventions
EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells
Genetically engineered natural killer (NK) cells expressing dual chimeric antigen receptors targeting CSPG4 and GD2 are expanded ex vivo and infused (IV) into patients. These cells recognize tumor antigens and induce targeted cytotoxicity, aiming to improve tumor killing and reduce antigen escape in CSPG4/GD2-positive cancers.
Fludarabine
Fludara
Cyclophosphamide
Cyclophosphamide
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China