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

Recruiting now · Phase 1/Phase 2

Conditions studied: Unresectable Melanoma, Metastatic Cutaneous Melanoma, Metastatic Uveal Melanoma

In brief

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

Key facts

Study ID

NCT07627698

Run by

Beijing Biotech

People needed

36

Starts

2026-03-02

Expected to finish

2028-06-17

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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