OncoMatch/Clinical Trials/NCT07627698
Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma
Is NCT07627698 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1/2 trial studies multiple treatments including EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells and Fludarabine for unresectable melanoma.
Treatment: EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells · Fludarabine · Cyclophosphamide — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Melanoma
Biomarker criteria
Required: CSPG4 expression (≥25% viable tumor cells by IHC or equivalent validated assay)
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)
Required: GD2 expression (≥25% viable tumor cells by IHC or equivalent validated assay)
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)
Disease stage
Required: Stage IV
Metastatic disease required
unresectable/metastatic cutaneous melanoma or metastatic uveal melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-PD-1 therapy — cutaneous melanoma
For cutaneous melanoma: prior anti-PD-1/L1 (with or without antiCTLA-4) unless contraindicated
Must have received: anti-PD-L1 therapy — cutaneous melanoma
For cutaneous melanoma: prior anti-PD-1/L1 (with or without antiCTLA-4) unless contraindicated
Must have received: anti-CTLA-4 therapy — cutaneous melanoma
For cutaneous melanoma: prior anti-PD-1/L1 (with or without antiCTLA-4) unless contraindicated
Must have received: BRAF inhibitor — BRAF V600-mutant cutaneous melanoma
if BRAF V600-mutant, prior BRAF/MEK inhibitor therapy or documented unsuitability
Must have received: MEK inhibitor — BRAF V600-mutant cutaneous melanoma
if BRAF V600-mutant, prior BRAF/MEK inhibitor therapy or documented unsuitability
Must have received: tebentafusp (tebentafusp) — HLA-A*02:01-positive metastatic uveal melanoma
For uveal melanoma: prior tebentafusp if HLA-A*02:01-positive and eligible, or documented unsuitability/unavailability plus at least one prior systemic therapy
Must have received: systemic therapy — uveal melanoma
For uveal melanoma: ...plus at least one prior systemic therapy
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant or solid organ transplant
Cannot have received: solid organ transplant
Prior allogeneic stem cell transplant or solid organ transplant
Lab requirements
Blood counts
adequate bone marrow function per protocol
Kidney function
adequate renal function per protocol
Liver function
adequate hepatic function per protocol
Cardiac function
adequate cardiac function per protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07627698 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplant, solid organ transplant disqualifies patients from enrollment.
Does this trial require CSPG4?
Yes, CSPG4 expression is a required biomarker for enrollment.
Does this trial require GD2?
Yes, GD2 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages