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

Exclusion Criteria

• •1. Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (≥Grade 3) to XH001 injection and/or any of its excipients.
• •2. Central nervous system metastases with symptoms and without prior treatment, and/or meningeal metastases.
• •3. Having received immunomodulatory drug therapy within 2 weeks prior 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 recovered to CTCAE grade≤2, excluding hair loss.
• •6. Subjects who received systemic steroid treatment (daily dose exceeding 10mg of prednisone equivalent) or any other form of immunosuppressive treatment within 7 days before the first administration of XH001 injection, excluding:1) Intranasal inhalation of local steroids or local steroid injection (such as intra-articular injection); 2) Systemic corticosteroid treatment not exceeding 10mg/day of prednisone or its equivalent physiological dose.
• •7. Subjects who have previously received therapeutic tumor vaccines or therapeutic cell therapy products.
• •8. Previously received allogeneic hematopoietic stem cell or allogeneic bone marrow transplantation, or previously received solid organ transplantation, or currently using immunosuppressive drugs.
• •9. Have active or poorly controlled severe infections during screening period.
• •10. Virological tests show positive for human immunodeficiency virus antibodies, hepatitis B surface antigen and/or hepatitis B core antibody with hepatitis B virus DNA \> 1000 IU/ml, positive for hepatitis C virus antibodies, and positive for Treponema pallidum specific antibodies.
• •11. Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma.
• •12. Any history of autoimmune diseases.
• •13. Known to have active pulmonary tuberculosis (TB).
• •14. Patients who have received systemic chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, hormone therapy or unapproved clinical trial drugs/instruments within 2 weeks before screening.
• •15. Subjects who are still participating in other clinical trials during the screening period.
• •16. Pregnant or lactating women.
• •17. Other severe, acute, or chronic medical or psychiatric conditions, or laboratory abnormalities, that, to the investigator's discretion, may increase the risks of participating in the trial or may interfere with the interpretation of the trial results.