GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis

This study is a single-arm, open-label clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GK01 cell therapy in patients with gastric cancer and peritoneal metastasis.

Inclusion Criteria: 1. Understands and voluntarily signs the informed consent form (ICF) before any study-related assessments/procedures are performed; 2. Age ≥18 years at the time of signing the ICF; 3. Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma, with no prior systemic therapy for locally advanced or metastatic gastric cancer (including targeted therapy, immunotherapy, and biologic therapy). If neoadjuvant or adjuvant therapy has been received, disease progression or recurrence must have occurred ≥6 months after the completion of neoadjuvant or adjuvant therapy. 4. At least one lesion ; 5. At least 1 measurable lesion (according to the RECIST 1.1 criteria); 6. ECOG performance status of 0 or 1 ; 7. Expected survival of more than 3 months; 8. Adequate hematologic and organ reserve function; Exclusion Criteria: 1. A history of severe allergy or hypersensitivity to any component of any drug to be used in this study, including but not limited to the planned chemotherapeutic agents and GK01 excipients (e.g., dimethyl sulfoxide); 2. Participation in a clinical trial within 28 days before signing the informed consent form; 3. Receipt of extensive radiotherapy within 28 days before signing the ICF, except for radiotherapy administered locally for symptom relief to non-target lesions within 14 days before signing the ICF or anticipated during the study period; 4. Major surgery within 28 days before signing the ICF (except endoscopic exploration for diagnostic purposes), or major surgery anticipated during the study period; 5. At the time of signing the ICF, toxicities caused by prior antitumor therapy have not recovered to Grade 1 or baseline, except for alopecia and hyperpigmentation (according to NCI-CTCAE version 6.0); 6. Any uncontrolled active infection at the time of signing the ICF or within 4 weeks before the first infusion that requires parenteral antibiotic, antiviral, or antifungal therapy; 7. Active or prior autoimmune disease with the potential for recurrence (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, and psoriasis), or at risk of such disease; 8. A history of prior bone marrow or organ transplantation; 9. Concurrent or prior history of interstitial lung disease or interstitial pneumonitis; 10. A history of active pulmonary tuberculosis infection within 1 year before screening (except for participants with a history of active pulmonary tuberculosis infection more than 1 year previously who, as judged by the investigator, currently have no evidence of active pulmonary tuberculosis); 11. A history of other primary malignant tumors within 5 years before study treatment; 12. Clinically significant cardiovascular disease; 13. A history of bleeding within 6 months before signing the ICF; clinically significant, evident bleeding risk or tendency (any bleeding or bleeding event of Grade ≥3 within 28 days before screening, including esophageal variceal bleeding); 14. Metabolic disorders, such as poorly controlled diabetes mellitus (glycated hemoglobin ≥8.5%), or other non-malignant organ or systemic diseases or secondary reactions to cancer that may result in a higher medical risk and/or uncertainty in the assessment of survival; 15. Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic central compression; or a prior history of CNS disease, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, and Parkinson disease; 16. Concurrent obstruction; 17. Receipt of a live attenuated/inactivated vaccine within 28 days before signing the ICF, or planned administration of a live attenuated/inactivated vaccine during the screening period; 18. Requirement for systemic corticosteroids (at a dose equivalent to or higher than 10 mg/day prednisone) or other immunosuppressive therapy within 14 days before harvest or during the study; 19. Participants who are positive for hepatitis B surface antigen (HBsAg) at screening must be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, participants with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection must be excluded; participants who are positive for hepatitis C virus (HCV) antibody; participants who are positive for human immunodeficiency virus (HIV) antibody; participants who are positive for cytomegalovirus (CMV) DNA; participants who are positive for Treponema pallidum-specific antibody; 20. Complications or other conditions that, in the opinion of the investigator, may affect compliance with the protocol or render the participant unsuitable for participation in this study.