Spots Global Cancer Trial Database for Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

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Trial Identification

Brief Title: Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

Official Title: Tumor Associated Antigen-specific Engineered Immune Effector Cells (EIE) Against Cancer

Study ID: NCT03535246

Conditions

Cancer

Interventions

Engineered Immune Cells

Study Description

Brief Summary: The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).

Detailed Description: Malignant tumor is still a major challenge in medicine and requires technology breakthrough, and its mortality rate is the highest among all diseases. World Health Organization and the American Cancer Association expect about 12 million new cancer patients worldwide each year, with about 8 million cancer deaths (20 thousand cancer deaths per day). At present, more than 20 million people are suffering from cancer, and this figure will increase to 75 million in 2030. In Asia, the incidence of cancer is expected to rise by 60% in 2020, and the number of cancer related deaths will reach 7 million annually in 2030. The incidence of lung, Intestine, breast, prostate and gastric cancer is high, and lung, Intestine, breast and liver cancer are the main causes of cancer related deaths in Asia. Adoptive immunotherapy based on cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. In vitro induction of tumor antigen-specific immune cells and engineering of target specific immune cells have great potential for cancer eradication. The study aims to evaluate the safety and efficacy of ex vivo manipulated EIE cells including chimeric antigen receptor (CAR) modified immune cells in treating cancer. The primary study objectives are to evaluate the safety of the investigational product, autologous EIE cells, to subjects by intravenous and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous EIE cells ex vivo, and (2) to determine the anti-cancer efficacy of the EIE cells.