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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multicenter phase 1/2 trial evaluating the safety, feasibility, and preliminary anti-tumor activity of allogeneic CSPG4/GD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic melanoma. The therapy uses an OR-gate/tandem CAR to recognize CSPG4 or GD2 and includes a safety switch; a 3+3 dose-escalation step identifies a recommended RP2D, followed by expansion cohorts. Key secondary endpoints include objective response, disease control, durability, progression-free survival, overall survival, CAR-NK persistence, and biomarker-response relationships.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

* 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's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.