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RECRUITING
NCT07551362
PHASE1/PHASE2

Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

Summary

This example planning study proposes a phase 1/2 evaluation of an allogeneic, cord-blood-derived dual-target CAR-NK product directed against CLDN18.2 and HER2 (ERBB2) in adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma after prior standard systemic therapy. CLDN18.2 is selected as the anchor antigen because it has the more disease-specific gastric/GEJ cell-therapy development footprint, while HER2 is retained as the complementary second antigen to address co-expressing or heterogeneous disease. Phase 1 uses a 3+3 dose-escalation design after fludarabine/cyclophosphamide lymphodepletion followed by three intravenous CAR-NK infusions on Days 0, 3, and 7. Phase 2 expansion evaluates the recommended phase 2 dose and preliminary antitumor activity

Official title: A Phase 1/2, Open-label, Multicenter Study of Allogeneic Dual-target CLDN18.2/HER2 (ERBB2) CAR-NK Cells After Fludarabine/Cyclophosphamide Lymphodepletion in

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03-02

Completion Date

2028-03-17

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-DT-CAR-NK

Allogeneic, cord-blood-derived CAR-NK cells engineered to target CLDN18.2 and HER2 (ERBB2). Planned phase 1 dose levels: 2 x 10\^6, 4 x 10\^6, and 8 x 10\^6 cells/kg/infusion. Administered intravenously on Days 0, 3, and 7.

DRUG

Fludarabine

Lymphodepleting chemotherapy administered intravenously at 30 mg/m\^2/day on Days -5 to -3.

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy administered intravenously at 500 mg/m\^2/day on Days -5 to -3.

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China