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

Sponsor
Beijing GoBroad Hospital
Study ID
NCT07329894
Phase
PHASE1
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • XH001 injection — DRUG
    mRNA tumor neoantigen vaccine
  • Tumor vaccine-induced specific T-cell injection — DRUG
    Adoptive T Cell Therapy

Study Details

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?

Key Dates

First listed
Jan 9, 2026
Start date
Feb 28, 2026
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Tumor neoantigen vaccine and tumor vaccine-induced specific T-cell Arm 1
    Tumor neoantigen vaccine; Tumor vaccine-induced specific T-cell Dose 1
  • Experimental: Tumor neoantigen vaccine and tumor vaccine induced specific T-cell Arm 2
    Tumor neoantigen vaccine; Tumor vaccine induced specific T-cell dose 2

Primary Outcome Measure

Adverse event [ Time Frame: 12 months ]

Central Contacts

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