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Recruiting Phase 1 / Phase 2

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

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About this study

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

Condition
Unresectable Melanoma, Metastatic Cutaneous Melanoma, Metastatic Uveal Melanoma
Tested
EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells, Fludarabine, Cyclophosphamide
Sponsor
Beijing Biotech

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Unresectable Melanoma, Metastatic Cutaneous Melanoma, Metastatic Uveal Melanoma
  • 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.
  • For cutaneous melanoma: prior anti-PD-1/L1 (with or without antiCTLA-4) unless contraindicated; if BRAF V600-mutant, prior BRAF/MEK inhibitor therapy or documented unsuitability.
  • For uveal melanoma: prior tebentafusp if HLA-A\*02:01-positive and eligible, or documented unsuitability/unavailability plus at least one prior systemic therapy.
  • Tumor demonstrates CSPG4 and/or GD2 expression in archival or fresh tissue by central testing (suggested positivity threshold: at least 25% viable tumor cells by IHC or equivalent validated assay).
  • At least 1 measurable lesion by RECIST v1.1.
  • ECOG performance status 0-1.
  • Adequate bone marrow, renal, hepatic, cardiac, and pulmonary function per protocol.
  • Life expectancy of at least 12 weeks.
  • Treated, stable brain metastases are allowed if neurologically stable for at least 4 weeks and not requiring escalating corticosteroids.
  • Willingness to use effective contraception and comply with protocol-required visits, blood sampling, and requested biopsies.

Exclusion 8

  • Active symptomatic CNS metastases, leptomeningeal disease, or uncontrolled seizure disorder.
  • Prior allogeneic stem cell transplant or solid organ transplant; prior gene-modified cellular therapy within 12 weeks; or anti-cancer therapy too close to lymphodepletion per protocol washout rules.
  • Requirement for systemic immunosuppression greater than 10 mg prednisone equivalent/day or uncontrolled autoimmune/inflammatory disease requiring systemic treatment.
  • Active uncontrolled infection, including uncontrolled HIV, HBV, or HCV, or fever/sepsis at the time lymphodepletion would begin.
  • Clinically significant cardiovascular disease, uncontrolled arrhythmia, recent myocardial infarction, or uncontrolled thromboembolic disease.
  • Grade 2 or higher unresolved toxicities from prior therapy, except stable endocrinopathy, alopecia, or vitiligo.
  • Pregnancy or breastfeeding.
  • Any condition that, in the investigator's judgment, would make lymphodepletion or CAR-NK infusion unsafe.

Where

1 site, 1 recruiting

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.