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Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma

NCT07492628 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

EB-DT-NK-UC101

Allogeneic cord-blood-derived dual-target Nectin-4/HER2 CAR-NK cells with inducible caspase-9 safety switch.

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy given before the first CAR-NK infusion.

DRUG

Fludarabine

Lymphodepleting chemotherapy given before the first CAR-NK infusion

Sponsors & Collaborators

  • Beijing Biotech

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2027-06-14
Completion
2028-05-17

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492628 on ClinicalTrials.gov