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

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 fludarabin

Trial Details

NCT ID

NCT07551362

Phase

PHASE1 / PHASE2

Sponsor

Beijing Biotech

Status

RECRUITING

Cancer Type

Gastric Cancer

Interventions

EB-DT-CAR-NK
Fludarabine
Cyclophosphamide

Locations (sample)

Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

Signed informed consent before any study-specific procedure.
Age 18 to 75 years.
Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Central confirmation of CLDN18.2-positive disease by immunohistochemistry, defined for this draft as membranous CLDN18.2 expression in at least 10%…

For full eligibility, visit ClinicalTrials.gov.

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