Phase 1 CLDN18.2/HER2 CAR-NK Cells, Advanced Gastric Cancer
ClinicalTrials.gov Studies
Summary
Phase 1 clinical trial registration (NCT07551362) for an allogeneic cord-blood-derived dual-target CAR-NK cell product directed against CLDN18.2 and HER2 antigens in adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma following prior standard systemic therapy. The trial uses a 3+3 dose-escalation design after lymphodepletion, with three intravenous infusions administered on Days 0, 3, and 7. Phase 2 will evaluate the recommended Phase 2 dose and preliminary antitumor activity.
“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.”
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What changed
This document registers a Phase 1 clinical trial (NCT07551362) evaluating an allogeneic cord-blood-derived CAR-NK product targeting both CLDN18.2 and HER2 in adults with advanced gastric or gastroesophageal junction adenocarcinoma. The study employs a 3+3 dose-escalation design following fludarabine/cyclophosphamide lymphodepletion, with three intravenous CAR-NK infusions administered on Days 0, 3, and 7. Phase 2 will assess the recommended Phase 2 dose and preliminary antitumor activity.
Healthcare providers and clinical investigators involved in oncology or cell therapy development should note this trial represents a novel dual-targeting approach combining an anchor antigen (CLDN18.2) with a complementary antigen (HER2) to address potential antigen heterogeneity. The trial population consists of adults with unresectable or metastatic disease who have already received standard systemic therapy.
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Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer
Phase 1 NCT07551362 Kind: PHASE1 Apr 24, 2026
Abstract
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
Conditions: Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
Interventions: EB-DT-CAR-NK, Fludarabine, Cyclophosphamide
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