Who may be eligible for the Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma trial?

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.

ClinicalTrials.gov record NCT07627698

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

An Open-Label, Multicenter Phase 1/2 Study of Allogeneic Dual-Target CSPG4/GD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous Melanoma or Metastatic Uveal Melanoma

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).

Age18 years old to 75 years old

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label Phase 1/2 study evaluates the safety, feasibility, and recommended Phase 2 dose of EB‑DTKN‑401, an allogeneic dual-target CSPG4/GD2 CAR‑NK cell product given after lymphodepleting chemotherapy. It is for adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease progressed after standard therapy and whose tumors express CSPG4 and/or GD2. The trial uses dose escalation followed by expansion cohorts for cutaneous and uveal melanoma.

What it is studying. The study tests safety, feasibility, and the recommended Phase 2 dose (RP2D) of EB‑DTKN‑401 — donor-derived NK cells engineered with dual CARs for CSPG4 and GD2 and an inducible caspase-9 safety switch — when given after lymphodepleting chemotherapy. It will also collect early data on tumor response, CAR‑NK persistence, and relationships between baseline biomarkers and response.

What the researchers hope to learn. Primary scientific goals: assess dose-limiting toxicities and define the recommended Phase 2 dose. Key secondary goals: record treatment-emergent adverse events (including CRS, ICANS, prolonged cytopenias, neuropathic pain, ocular toxicity, and GVHD), measure objective response rate and disease control by RECIST v1.1, and evaluate duration of response, progression-free survival, overall survival, CAR‑NK persistence, and baseline biomarker–response relationships.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Fludarabine
Cyclophosphamide
Biological: EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The target-selection review favored CSPG4/GD2 because it gives the strongest melanoma-centered rationale across both cutaneous and uveal disease. EBDTKN-401 is an allogeneic donor-derived NK-cell product engineered with an OR-gate/tandem CAR recognizing CSPG4 or GD2 and an inducible caspase-9 safety switch. Part A uses 3+3 dose escalation to identify the RP2D. Part B evaluates the RP2D in expansion cohorts for cutaneous melanoma and uveal melanoma. Key secondary objectives are objective response, disease control, durability, progression-free survival, overall survival, CAR-NK persistence, and baseline biomarker-response relationships.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have their tumor tested (archival tissue or a fresh biopsy) for CSPG4/GD2 and undergo screening tests. Before infusion they receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide), then receive EB‑DTKN‑401 CAR‑NK cell infusions (dose‑escalation participants may receive up to three infusions over 15 days; expansion cohorts receive the recommended phase 2 dose after the same lymphodepletion). Study visits include blood tests, imaging scans to measure tumors (RECIST), safety monitoring for side effects (including cytokine release syndrome, neurologic events, prolonged low blood counts, ocular toxicity, or graft‑versus‑host disease), and possible additional tumor biopsies. Participants must agree to contraception requirements and will have follow‑up visits to monitor safety and tumor response for up to 24 months per protocol.

How the study is structured. Interventional, open-label Phase 1/2 trial. Part A is a 3+3 dose-escalation safety lead-in to identify the RP2D; Part B expands at the RP2D in separate cutaneous and uveal melanoma cohorts. Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by EB‑DTKN‑401 infusions (Arm A allows up to three infusions over 15 days in escalation). No masking is used.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Unresectable Melanoma; Metastatic Cutaneous Melanoma; Metastatic Uveal Melanoma. Does it apply to my diagnosis?
This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 2, 2026
Primary completion: Jun 14, 2027 (estimated)
Study completion: Jun 17, 2028 (estimated)
Target enrollment: 36 participants (estimated)
Last updated on registry: Jun 4, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Beijing Biotech

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Seni S Lu, Phd 📞 +86 13076790030 ✉ Seni-Lu@beijing-biotech.com

Participating sites (1)

Peking University Shenzhen HospitalRecruiting
Shenzhen, Guangdong, 518036 · China
- Zhen J Peng, Phd · +86 13076790039 · Zhen-Peng@beijing-biotech.com

Terms used on this page · explanations by MedicalUpdates.ai

first-in-human: The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
recommended phase 2 dose: The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
standard therapy: Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
Histologically confirmed: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
contraindicated: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
ECOG performance status: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Life expectancy: Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
corticosteroids: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
allogeneic stem cell transplant: A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
washout: A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
prior therapy: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
3+3: Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
progression-free survival: The length of time during and after treatment that a person lives without the condition getting worse, as defined by the study.
overall survival: The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
biomarker: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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