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

Inclusion 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. 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.