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

StatusRecruiting
PhasePhase 1
Started2026-02
View on ClinicalTrials.gov ↗

Amendment history

2026-02-10
Not Yet Recruiting→Recruiting Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-07→2027-08
Start date2026-01→2026-02
Study arms1→2
InterventionsTumor Neoantigen vaccine-induced tumor-specific T-cell injection (Drug), XH001 injection (Drug)→Tumor vaccine-induced specific T-cell injection (Drug), XH001 injection (Drug)
Eligibility criteria-57 characters
[...] rogression for this lesion. Expected survival duration ≥ 12 monthsweeks. Adequate organ and bone marrow function. Exclusion Criteri [...] (≥Grade 3) to XH001 injection and/or any of its excipients. 2. Central nervous system metastases with symptoms, and/or meningeal metastases. 3. Having received immunomodulatory drug therapy within 2 weeks [...] or to the first administration day (D1) of XH001 injection. 4. Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis). 5. Subjects with toxic side effects from previous treatment that have not recovere [...] [...]
Secondary endpoints4 to 6 entries
BOR DOR
Primary endpoints2 entries, revised
AEAdverse event
Study sitesdetails revised at 1 of 1 site
2025-12-29
Original filing
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?
Trial Details
NCT Number NCT07329894
Lead Sponsor Beijing GoBroad Hospital
Collaborators: NeoCura
Conditions Gastrointestinal Cancer
Enrollment 18 participants
Start Date 2026-02
Primary Completion 2027-08 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-12