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

Must have received: standard treatment — second-line

has failed to respond to second-line standard treatment or is intolerant to it, or is not suitable for standard treatment at this stage

Cannot have received: immunomodulatory drug therapy

Having received immunomodulatory drug therapy within 2 weeks prior to the first administration day (D1) of XH001 injection

Cannot have received: systemic steroid treatment

Exception: Intranasal inhalation of local steroids or local steroid injection (such as intra-articular injection)Systemic corticosteroid treatment not exceeding 10mg/day of prednisone or its equivalent physiological dose

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

Cannot have received: therapeutic tumor vaccines

Subjects who have previously received therapeutic tumor vaccines

Cannot have received: therapeutic cell therapy products

Subjects who have previously received therapeutic cell therapy products

Cannot have received: allogeneic hematopoietic stem cell transplantation

Previously received allogeneic hematopoietic stem cell or allogeneic bone marrow transplantation

Cannot have received: solid organ transplantation

previously received solid organ transplantation, or currently using immunosuppressive drugs

Cannot have received: systemic chemotherapy

Patients who have received systemic chemotherapy...within 2 weeks before screening

Cannot have received: radiotherapy

Patients who have received...radiotherapy...within 2 weeks before screening

Cannot have received: molecular targeted therapy

Patients who have received...molecular targeted therapy...within 2 weeks before screening

Cannot have received: biological immunotherapy

Patients who have received...biological immunotherapy...within 2 weeks before screening

Cannot have received: hormone therapy

Patients who have received...hormone therapy...within 2 weeks before screening

Cannot have received: unapproved clinical trial drugs/instruments

Patients who have received...unapproved clinical trial drugs/instruments within 2 weeks before screening