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;
Single group
Biological/Vaccine
DrugFollowing lymphodepleting conditioning and a 2-3 day chemotherapy washout period, patients will begin receiving twice-weekly infusions of autologous cCTL cells. This study is designed such that the first three cCTL infusions for each patient will follow a stepwise dose escalation of the effective dose, specifically 1-2×107 cCTL/Kg、3-4×107 cCTL/Kg、4-5×107 cCTL/Kg; safety will be evaluated during this period to determine subsequent infusion doses. The target dose for this study is 4-5x107 cCTL/Kg per infusion, with a target frequency of twice weekly. This phase will last 2-3 weeks, with a total of 4-6 infusions. Based on the results of the first course of treatment, the investigator will determine whether to proceed with a second course of treatment. During treatment intervals, the investigator may administer bridging therapy based on the patient's clinical condition.
dose-limiting toxicities (DLTs)
To evaluate safety, the investigator will monitor the number of participants experiencing treatment-related adverse events (AEs) and dose-limiting toxicities (DLTs), assessing their incidence, type, severity, and causality. All AEs, including immunotherapy-related reactions such as cytokine release syndrome (CRS), will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The primary parameters to be evaluated are as follows: ①Blood pressure: Changes in patients' blood pressure will be closely monitored throughout the treatment. The measurement data will be reported and aggregated in millimeters of mercury (mmHg). ②Pulse: Patients' pulse will be continuously monitored throughout the trial to evaluate physiological stability and acute reactions following treatment administration. The measurement data will be reported in beats per minute (bpm). ③Inflammatory Markers: Blood inflammatory markers, specifically C-reactive prote
Objective response rate (ORR)
The percentage of participants achieving a Complete Response (CR) or Partial Response (PR). Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
disease control rate (DCR)
The percentage of participants achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD). This will be assessed according to RECIST v1.1.
Progression-free survival (PFS)
The time from the start of treatment to the date of first documented disease progression (assessed via RECIST v1.1) or death from any cause, whichever occurs first. Measurement data will be reported in weeks or months.
overall survival (OS)
The time from the start of treatment to the date of death from any cause. Measurement data will be reported in weeks or months.
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This trial is not recruiting at the moment. You can still explore other options:
