OncoMatch/Clinical Trials/NCT07492628
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma
Is NCT07492628 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07492628 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplant, solid-organ transplant disqualifies patients from enrollment.
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