Actively Recruiting
An Open-Label Phase 1/2 Study of Allogeneic Dual-Target CSPG4/GD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous or Uveal Melanoma
Led by Beijing Biotech · Updated on 2026-06-04
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, recommended dose for phase 2, and early anti-cancer effects of allogeneic dual-target CSPG4/GD2 CAR-NK cells (called EB-DTKN-401) in adults with advanced unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard treatments. This open-label, multicenter phase 1/2 study focuses on patients with tumors expressing CSPG4 and/or GD2, aiming to improve treatment options for these challenging melanoma types. The study includes three groups: a dose-escalation safety lead-in phase to find the recommended phase 2 dose, followed by expansion cohorts for cutaneous and uveal melanoma. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, then receive one to three infusions of EB-DTKN-401 over 15 days at varying dose levels. The CAR-NK cells are immune cells engineered to target two melanoma-associated proteins, aiming to enhance tumor killing and reduce immune escape. During the trial, participants will be closely monitored for dose-limiting toxicities and treatment side effects up to 12 months. Researchers will assess tumor response, disease control, duration of response, progression-free survival, overall survival, and persistence of CAR-NK cells over up to 24 months. Visits include clinical evaluations, imaging to measure tumors, blood tests, and biopsies. The total study duration varies by participant but includes safety assessments and long-term follow-up to evaluate treatment impact and patient outcomes.
CONDITIONS
Brief Title
Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 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 therapy (with or without anti-CTLA-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 shows CSPG4 and/or GD2 expression in tissue by central testing
- At least one measurable lesion by RECIST v1.1
- ECOG performance status 0-1
- Adequate bone marrow, kidney, liver, heart, and lung function
- Life expectancy of at least 12 weeks
- Treated, stable brain metastases allowed if neurologically stable for at least 4 weeks and not requiring increasing corticosteroids
- Willingness to use effective contraception and comply with study visits and sampling
You will not qualify if you...
- Active symptomatic central nervous system metastases, leptomeningeal disease, or uncontrolled seizure disorder
- Prior allogeneic stem cell or solid organ transplant
- Prior gene-modified cellular therapy within 12 weeks
- Anti-cancer therapy too close to lymphodepletion per washout rules
- Need for systemic immunosuppression over 10 mg prednisone equivalent/day or uncontrolled autoimmune/inflammatory disease requiring systemic treatment
- Active uncontrolled infection including HIV, HBV, or HCV
- Clinically significant cardiovascular disease or uncontrolled arrhythmia
- Recent heart attack or uncontrolled thromboembolic disease
- Grade 2 or higher unresolved toxicities from prior therapy except stable endocrinopathy, alopecia, or vitiligo
- Pregnancy or breastfeeding
- Any condition making lymphodepletion or CAR-NK infusion unsafe per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days
Participants receive lymphodepleting chemotherapy followed by up to three infusions of genetically engineered dual-target CSPG4/GD2 CAR-NK cells to target melanoma cells.
Multiple visits during treatment period for infusions and assessments
Duration - Up to 24 months
Participants are monitored for safety, treatment response, and overall health outcomes after completing treatment.
Scheduled visits over follow-up period for evaluations
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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