Grant Award Details
Grant Application Details
- Novel T cell receptor-STEM T cell immunotherapy in lung cancer
HLA-A*02 restricted CT83 antigen-specific T cell receptor-engineered T cell cells (CT83TCR-STEM T cells for short).
Area of Impact
Metastatic lung cancer patients who fail to respond to immune checkpoint therapy or prior treatment
Mechanism of Action
Despite the impressive clinical response to immune checkpoint inhibitors, the majority of lung cancer patients fail to respond to the immune checkpoint therapy and remains unmet medical need. The proposed candidate CT83TCR-STEM T cells are T cell receptor-engineered T cells that can recognize and eliminate CT83 antigen-expressing lung cancer, leaving normal cell untouched. This is because CT83 as tumor-specific target is highly expressed in lung cancer, but not in normal cells.
Unmet Medical Need
Despite the impressive clinical response to immune checkpoint inhibitors, the overall objective response rates in lung cancer patients are approximately 20%. Therefore, the majority of lung cancer patients fail to respond to the immune checkpoint therapy and remains unmet medical need.
Pre-IND meeting with FDA, ready for preparing IND
Major Proposed Activities
- Generate GMP-compliant Master and Working Cell Bank, viral particle production, and certificate testing required by FDA
- Non-clinical studies (biodistribution/fate of TCR-T cells, pilot toxicity), GMP-compatible scale up process of TCR-T cell product, stability tests
- Regulatory and clinical trial development (IRB protocol) and Pre-IND meeting with the FDA
Lung cancer is a leading cause of cancer-related deaths in California and Los Angeles county (LAC), which is one of the most racially and ethnically diverse regions in the US. There are alarming racial/ethnic disparities in lung cancer outcomes in LAC, our catchment area. HLA-A*02 is a global common and expressed in 40-50% of general population. CT83 is highly expressed in approximately 50-70% of human NSCLC lung cancer. Thus, the prosed research will benefit the state of California and LAC.