Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Soft Tissue Sarcoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

Immunotherapy is one of the most promising and effective methods to cure tumor besides operation, chemotherapy and radiotherapy. T cell therapy, which belongs to immunotherapy, mainly includes CAR-T (Chimeric Antigen Receptor, CAR) and TCR-T (T cell Receptor-T). The existing CAR-T treatment can only...

Immunotherapy is one of the most promising and effective methods to cure tumor besides operation, chemotherapy and radiotherapy. T cell therapy, which belongs to immunotherapy, mainly includes CAR-T (Chimeric Antigen Receptor, CAR) and TCR-T (T cell Receptor-T). The existing CAR-T treatment can only kill blood tumor cells, the effect on solid tumor treatment was not well. Therefore, people need a better method than CAR-T, which can kill tumor cell internal antigen and has better curative effect on solid tumor treatment, and has less side effect. This is the TCR-T cell treatment developed by the applicant now. In view of the cross reaction between tumor antigen and normal cell antigen, which is easy to cause adverse reactions, this mainly focuses on a kind of antigen that is not expressed in normal cells, but expressed in testis, and is defined as cancer testis antigen. The applicant preferred NY-ESO-1 antigen, which was first found in esophageal cancer, then 10-50% in melanoma, non-small cell lung cancer (NSCLC), liver cancer, breast cancer, prostate cancer, bladder cancer, thyroid cancer and ovarian cancer, 60% in multiple myeloma, 70-80% in synovial cell sarcoma and 22.5% in osteosarcoma. In 2015, the University of Pennsylvania, the University of Maryland and Adaptimmune in the United Kingdom reported the breakthrough progress of TCR-T cells in the world-class Journal of natural medicine. This clinical trial showed that high affinity anti-NYESO-1 and LAGE-1 specific TCR-T were effective in 16 (80%) of 20 patients with multiple myeloma, with an average progression free survival of 19.1 months, and the side effects were mild, without serious side effects of CAR-T. Another clinical trial of NY-ESO-1-specific TCR-T in the treatment of synovial cell sarcoma (synovial cell sarcoma) and melanoma by a team of Dr. Rosenberg from the National Cancer Research Institute of the United States showed that 61% of synovial cell sarcomas and 55% of melanoma had clinical effects. Due to the good clinical results of anti-NY-ESO-1-specific TCR-T of adaptimmune company in the treatment of synovial sarcoma, the US FDA approved this TCR-T cell treatment of synovial sarcoma to enter the breakthrough treatment These clinical data indicate that TCR-T cell therapy can be applied to a variety of tumors, including soft tissue sarcoma.

Tracking Information

NCT #
NCT04318964
Collaborators
Guangdong Xiangxue Precision Medical Technology Co., Ltd.
Investigators
Not Provided