OncoMatch/Clinical Trials/NCT07492628
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma
Is NCT07492628 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including EB-DT-NK-UC101 and Cyclophosphamide for bladder cancer.
Treatment: EB-DT-NK-UC101 · Cyclophosphamide · Fludarabine — This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4/HER2 CAR-NK cell product in adults with relapsed/refractory locally advanced or metastatic urothelial carcinoma. Based on public urothelial-cancer evidence, Nectin-4 was selected as the lead antigen because it has the strongest disease-specific clinical validation; HER2/ERBB2 was chosen as the secondary co-target to broaden tumor coverage and reduce antigen-escape risk. EpCAM is not selected as a therapeutic co-target in this example because of broader normal epithelial expression and weaker tumor specificity in urothelial carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Allowed: NECTIN4 overexpression
Tumor tissue available for central review demonstrating Nectin-4 positivity (for example, IHC ≥1+ in ≥10% tumor cells)
Allowed: HER2 (ERBB2) overexpression
HER2 status assessed by IHC/ISH. At least one of the selected therapeutic targets must be present
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Disease progression after, intolerance to, or ineligibility for standard therapy, including platinum-based chemotherapy
Must have received: anti-PD-1 therapy
Disease progression after, intolerance to, or ineligibility for standard therapy, including ... PD-1/PD-L1 blockade when appropriate for the patient and region
Must have received: anti-PD-L1 therapy
Disease progression after, intolerance to, or ineligibility for standard therapy, including ... PD-1/PD-L1 blockade when appropriate for the patient and region
Cannot have received: allogeneic hematopoietic stem cell transplant
Prior allogeneic hematopoietic stem cell transplant
Cannot have received: solid-organ transplant
prior solid-organ transplant
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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