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 Gastrointestinal Cancer

NCT07329894 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 gastrointestinal cancer in adults. It will also learn if the combined treatment works to treat advanced gastrointestinal 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	Beijing GoBroad Hospital
Phase	Phase 1
Status	RECRUITING
Enrolment	18
Start date	2026-02
Completion	2029-10

Conditions

• Gastrointestinal Cancer

Interventions

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

Primary outcomes

• Adverse event — 12 months
  Incidence and severity of adverse events as assessed by 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 this cell therapy.

Countries

China