Tumor-Specific T-Cells (cCTL:GL01) for Advanced Gastrointestinal Cancer

This clinical trial is designed to study an investigational cell therapy called cCTL-GL01 in patients with advanced gastrointestinal cancers (including cancers of the stomach, esophagus, colon, or rectum) that have not responded well to standard treatments. The main goals of this study are to find out: If cCTL-GL01 is safe and what side effects it might cause; How well cCTL-GL01 works to control or shrink tumors.

Inclusion Criteria: * Age 18 to 65 years (inclusive), male or female; * Ability to understand the study and has signed the written Informed Consent Form (ICF), and is willing and able to comply with all protocol-required procedures; * Fresh tumor tissue samples can be obtained via biopsy or surgery, and peripheral blood mononuclear cells (PBMCs) can be obtained via apheresis; * Histologically and/or cytologically confirmed advanced gastrointestinal solid tumors (e.g., esophageal cancer, gastric cancer, colon cancer, etc.), with previous receipt of at least one systemic therapy that failed or resulted in recurrence; OR previous receipt of any form of immunotherapy or cellular therapy that failed or resulted in recurrence; * Presence of at least one measurable lesion according to RECIST v1.1, or has an evaluable target lesion/disease assessment method as determined by the investigator. (Note: A measurable lesion is defined as a non-nodal lesion with at least one dimension ≥ 10 mm, or a nodal lesion with a short axis ≥ 15 mm, measured by CT/MRI; lesions previously treated with local therapies \[e.g., radiotherapy\] cannot be considered as target lesions unless clear disease progression is documented.) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1; * Life expectancy ≥ 20 weeks; * Hepatitis B virus (HBV) infected patients (with HBV DNA levels below the lower limit of detection \[LLOD\]), or cured Hepatitis C virus (HCV) infected patients; * Laboratory values within 14 days prior to the first dose of study drug must meet the following criteria: 1. Hematology: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets (PLT) ≥100×109/L; Hemoglobin (Hb) ≥90g/L; Note: The above requirements must be met without receiving any transfusion of blood components or supportive therapy with cell growth factors within two weeks prior to blood collection. 2. Renal Function: Serum creatinine ≤1.5×upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥50mL/min (calculated using the Cockcroft-Gault formula). 3. Hepatic Function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×ULN (for patients with liver metastases, ALT and AST ≤3.0×ULN); Serum total bilirubin (TBIL) ≤1.5×ULN. 4. Coagulation Function: International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5×ULN (for patients receiving warfarin anticoagulation, INR must be between 1.5 and 2.5); activated partial thromboplastin time (aPTT) ≤1.5×ULN. * Female patients of childbearing potential must have a confirmed negative serum pregnancy test within 3 days prior to the first dose of study drug, and must initiate effective contraception immediately following the negative result; patients of childbearing potential and their partners must agree to use highly effective contraception throughout the study drug treatment period and for 90 days after the last dose of study drug. * Adverse events (AEs) related to prior anti-cancer therapy must have resolved to Grade 0 or 1; the following AEs are permitted for enrollment: alopecia, Grade ≤2 sensory neuropathy, and endocrine disorders controlled by hormone replacement therapy. Exclusion Criteria: * History of a second primary malignancy within 5 years (inclusive) prior to screening, except for cured cervical carcinoma in situ, localized skin squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ (DCIS) of the breast, \