Master Protocol to Assess the Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neoplasms
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Masking Description: This will be an open-label study. Hence, there will be no maskingPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1 have shown objective responses. GSK3901961 and GSK3845097 are next generation engine...
New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1 have shown objective responses. GSK3901961 and GSK3845097 are next generation engineered TCR T-cells, co-expressing the CD8? cell surface receptor, targeting NY-ESO-1, and co-expressing the dnTGF-?RII cell surface receptor, targeting NY-ESO-1, respectively to potentially improve function. This is a master protocol evaluating first time in human T-cell therapies. It will initially consist of two independent substudies, investigating GSK3901961 and GSK3845097 in HLA*A02+ participants with NYESO1+ previously treated advanced (metastatic or unresectable) synovial sarcoma (SS) and/or previously treated metastatic non-small cell lung cancer (NSCLC).
Tracking Information
- NCT #
- NCT04526509
- Collaborators
- Not Provided
- Investigators
- Study Director: GSK Clinical Trials GlaxoSmithKline
Get Well Soon