RecruitingPhase 1Phase 2NCT07627698

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

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


Sponsor

Beijing Biotech

Enrollment

36 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a biological treatment called EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells, and others for people with metastatic cutaneous melanoma, metastatic uveal melanoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEB-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.

DRUGFludarabine

Fludara

DRUGCyclophosphamide

Cyclophosphamide


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07627698


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