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

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

Trial Details

NCT ID
NCT07627698
Phase
PHASE1 / PHASE2
Sponsor
Beijing Biotech
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells
  • Fludarabine
  • Cyclophosphamide
Locations (sample)
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Age 18-75 years at consent.
  • Histologically confirmed unresectable/metastatic cutaneous melanoma or metastatic uveal melanoma.
  • Disease progression after standard therapy, intolerance to standard therapy, or no remaining standard option expected to provide meaningful benefit…
  • Tumor demonstrates CSPG4 and/or GD2 expression in archival or fresh tissue by central testing (suggested positivity threshold: at least 25% viable …

For full eligibility, visit ClinicalTrials.gov.

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