RecruitingPhase 1NCT07298200

Clinical Trial on the Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric 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 Gastric Cancer.


Sponsor

Jia Wei

Enrollment

18 participants

Start Date

Dec 26, 2025

Study Type

INTERVENTIONAL

Conditions

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 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?


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of a checkpoint blocker drug (XH001), a personalized cancer vaccine, and T-cell injections specifically designed to target that patient's cancer mutations in people with advanced stomach cancer that has stopped responding to previous treatments. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with advanced gastric (stomach) cancer confirmed by biopsy - Your cancer has not responded to at least two prior lines of standard treatment - You are in reasonably good physical condition - You have measurable disease on imaging **You may NOT be eligible if...** - Your cancer has spread to the brain - You have serious autoimmune conditions - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You are currently taking steroids or immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXH001 Injection

mRNA tumor neoantigen vaccine

DRUGTumor vaccine-induced specific T-cell injection

Adoptive Cell Transfer Therapy product


Locations(1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

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NCT07298200


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