NCT07329894

Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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?

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
DRUG	XH001 injection	mRNA tumor neoantigen vaccine
DRUG	Tumor vaccine-induced specific T-cell injection	Adoptive T Cell Therapy

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-08-01
• Completion: 2029-10-01
• First posted: 2026-01-09
• Last updated: 2026-02-12

Locations

1 site across 1 country: China