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

NCT07627698 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-04

No results posted yet for this study

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

Conditions

  • Unresectable Melanoma
  • Metastatic Cutaneous Melanoma
  • Metastatic Uveal Melanoma

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

Sponsors & Collaborators

  • Beijing Biotech

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2027-06-14
Completion
2028-06-17

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07627698 on ClinicalTrials.gov