NCT07627698 Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma
| NCT ID | NCT07627698 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Biotech |
| Condition | Unresectable Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-06-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-03-02 with a primary completion date of 2027-06-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07627698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Unresectable Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07627698 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07627698 currently recruiting?
Yes, NCT07627698 is actively recruiting participants. Contact the research team at Seni-Lu@beijing-biotech.com for enrollment information.
Where is the NCT07627698 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07627698 clinical trial?
NCT07627698 is sponsored by Beijing Biotech. The trial plans to enroll 36 participants.
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