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

Sponsor
Beijing Biotech
Study ID
NCT07492628
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • EB-DT-NK-UC101 — BIOLOGICAL
    Allogeneic cord-blood-derived dual-target Nectin-4/HER2 CAR-NK cells with inducible caspase-9 safety switch.
  • Cyclophosphamide — DRUG
    Lymphodepleting chemotherapy given before the first CAR-NK infusion.
  • Fludarabine — DRUG
    Lymphodepleting chemotherapy given before the first CAR-NK infusion

Study Details

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.

Key Dates

First listed
Mar 25, 2026
Start date
Mar 2, 2026
Status verified
Mar 2026
Primary completion
Jun 14, 2027
Completion
May 17, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants receive lymphodepletion with cyclophosphamide and fludarabine followed by EB-DT-NK-UC101 IV infusions on Day 1 and Day 8 of a 21-day cycle. Planned dose levels: 1 × 10\^7, 3 × 10\^7, and 1 × 10\^8 CAR-NK cells/kg
  • Experimental: Dose Expansion
    Participants receive the RP2D identified in Arm A using the same lymphodepletion backbone and infusion schedule. Expansion enriches for Nectin-4-positive disease and captures HER2 co-expression prospectively.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 Days ]

Central Contacts

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