All Drugs and Chemicals

Immunomodulating Agents

engineered immune cells

Lung-Ji Chang, PhD

Yichun Cai, MD

Xun Lai, MD

The primary objectives are to evaluate the safety and efficacy of infusion of autologous gastro-intestinal (GI) cancer antigen-specific engineered immune effector cells (EIE).

Gastro-intestinal (GI) cancer is becoming the top-ranked high mortality cancer in recent years. Every year, approximate 5,300,000 people in China are diagnosed with cancer, of which about 2,000,000 die each year, and esophagus cancer, gastric cancer and colorectal cancer account for \~50% of all GI cancer cases. GI cancer causes 500 thousand deaths a year. In China, nearly 85% of patients with cancer of the digestive tract are in middle to late stage at diagnosis. Regardless of the treatment, the five year survival rate is only 36%. GI cancers include cancer in the oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum) and large intestine (cecum, colon, rectum). The main malignant tumors of the GI tract are esophageal, gastric, colorectal, liver, and pancreatic cancer.

Adoptive immunotherapy based on cytotoxic T lymphocytes reactive with specific antigens has proven to be effective in many studies. In vitro induction of cancer antigen-specific immune cells and genetic engineering of target specific immune cells have great potential for cancer eradication. This 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 injections. 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.

Immunotherapy Treating GI Cancer

Antigen-specific Engineered Immune Effector Cells (EIE) Against Gastro-Intestinal (GI) Cancer

To assess the safety of autologous EIE cells in patients. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

The percentage of successful EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.

measurement of tumor marker in blood and examination of tumor size change

Objective response (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Shenzhen Geno-Immune Medical Institute

Engineered Immune Cells

Xun Lai, MS

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

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.

Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

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

To assess the safety of autologous EIE cells in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

measurement of TAA concentration in blood sample

Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy Treating GI Cancer	NCT03614650	Cancer	engineered immu...	1 Year - 80 Years	Shenzhen Geno-Immune Medical Institute
Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells	NCT03535246	Cancer	Engineered Immu...	1 Year - 80 Years	Shenzhen Geno-Immune Medical Institute
Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells	NCT03535246	Cancer	Engineered Immu...	1 Year - 80 Years	Shenzhen Geno-Immune Medical Institute
Immunotherapy Treating GI Cancer	NCT03614650	Cancer	engineered immu...	1 Year - 80 Years	Shenzhen Geno-Immune Medical Institute

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