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.
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;
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, <T1 urothelial carcinoma, or prostate cancer under active surveillance;
Patients with Gilbert's syndrome;
Patients with anorexia, nausea, or vomiting of Grade≥2;
History of bowel obstruction or intestinal perforation within 6 months prior to screening;