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RECRUITING
NCT07627698
PHASE1/PHASE2

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

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

DRUG

Fludarabine

Fludara

DRUG

Cyclophosphamide

Cyclophosphamide

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China