A Single-center, Non-randomized, Open-label Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer.

NCT07298200 Phase 1 RECRUITING

The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastric cancer in adults. It will also learn if the combined treatment works to treat advanced gastric cancer. The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?

Details

Lead sponsor	Jia Wei
Phase	Phase 1
Status	RECRUITING
Enrolment	18
Start date	2025-12-26
Completion	2029-11

Conditions

• Advanced Gastric Cancer

Interventions

• XH001 Injection
• Tumor vaccine-induced specific T-cell injection

Primary outcomes

• Adverse Event — 12 months
  Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (Based on Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0).
• Dose Limiting Toxicity — From reinfusion of neoantigen vaccine-induced tumor-specific T cells to 28 days after the reinfusion.
  Safety events occurring within 28 days after the reinfusion of neoantigen vaccine-induced tumor-specific T cells and related to neoantigen vaccine-induced tumor-specific T cells.

Countries

China