NCT03535246

Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Engineered Immune Cells	Engineered immune effector cells (EIE)

Timeline

• Start date: 2018-07-01
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2018-05-24
• Last updated: 2019-09-19

Locations

3 sites across 1 country: China