Patients with late malignant digestive tract tumor, for example metastatic colorectal cancer, pancreatic cancer, gastric cancer and so on. because of this is a open, single arm trail, there is no control group.

Patients with advanced malignant gastrointestinal tumors were injected with CART cells

gucy2c cart cells

Weijia Fang

Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.

The primary objective of phase 1 is to evaluate the safety of CART regimens. The primary objective of phase 2 is to evaluate the efficacy of CART, as measured by objective response rate in subjects with colorectal cancer. Secondary objectives will include assessing the safety and tolerability of CART and additional efficacy endpoints.

CART Therapy in GUCY2C-positive Digestive Tract Tumors

Clinical Study on the Safety and Efficacy of CART Cells in the Treatment of Advanced GUCY2C-positive Digestive Tract Tumors

The investigator is responsible for ensuring that all adverse events observed by the investigator or reported by the subject during the 3-month period from enrollment (i.e. initiation of leukocyte separation) to 3 months after targeted car-t infusion are monitored and reported. After three months, researchers will be required to monitor and report targeted adverse events, including neurological, blood, infection, autoimmune diseases, and secondary malignant tumors, for 24 months or until disease progression, whichever occurs first.

We will summarize the classification of cytokine release syndrome (CRS) according to the severity and system organ classification.

Remission will be evaluated by the central investigator at the time indicated in the evaluation plan. The disease was evaluated according to the response evaluation criteria in solid tumors RECIST version 1.1 or EORTC or percist. Flow cytometry, molecular or cytogenetic studies used in the trial will be used to assist, but will not be used alone to determine remission.

Innovative Cellular Therapeutics Co., Ltd.

Weijia Fang, MD

director

Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Yifu He

Daiyan Liu

Yifu he

Chimeric Antigen Receptor T Cells (CART) Therapy in GUYC2C postive Digestive system tumors, include colorectal cancer, gastric cancer, liver cancer, pancreatic cancer, adenocarcinoma of esophagus, cancer of the esophagogastric junction.

Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CART Therapy in GUCY2C-positive Digestive Tract Tumors	NCT04652219	Malignant Neopl...	gucy2c cart cel...	18 Years - 70 Years	Zhejiang University
CART Therapy in Digestive System Tumors	NCT04780529	Malignant Neopl...	gucy2c cart cel...	18 Years - 70 Years	Innovative Cellular Therapeutics Co., Ltd.
CART Therapy in Digestive System Tumors	NCT04780529	Malignant Neopl...	gucy2c cart cel...	18 Years - 70 Years	Innovative Cellular Therapeutics Co., Ltd.

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