Master Protocol to Assess the Safety and Antitumour Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumours

Official Title

Master Protocol to Assess the Safety and Antitumour Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumours (IGNYTE-ESO)

Summary:

This trial will evaluate safety and efficacy of GSK3377794 in participants with solid tumours, initially in participants with synovial sarcoma. Adoptive T-cell therapy (ACT) is a therapeutic approach that uses T lymphocytes of participants with cancer, obtained by leukapheresis, with the aim of generating an anti-tumour T-cell immune response.

Trial Description

Primary Outcome:

• Substudy 1: Overall response rate
• Substudy 2: Overall response rate

Secondary Outcome:

• Substudy 1 and 2: Time to response
• Substudy 1 and 2: Duration of response
• Substudy 1 and 2: Disease control rate
• Substudy 1 and 2: Progression free survival
• Substudy 1 and 2: Number of partiipants with adverse events (AEs) and serious adverse events (SAEs)
• Substudy 1 and 2: Severity and duration of adverse events of special interest (AESIs)
• Substudy 1 and 2: Number of participants with replication competent lentivirus (RCL)
• Substudy 1 and 2: Number of participants with insertional oncogenesis
• Substudy 1 and 2: Number of participants with clinically significant changes in hematology and clinical chemistry parameters
• Substudy 1 and 2: Number of participants with clinically significant changes in urinalysis parameters
• Substudy 1 and 2: T Cell Persistence of GSK3377794
• Substudy 2: Number of participants with positive anti-drug antibodies (ADA) against GSK3377794
• Substudy 2: Titers of ADA against GSK3377794

New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumour-associated proteins that have been found in several tumour types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses. GSK3377794 is the first generation of NY-ESO-1 specific T-cell receptor engineered T-cells. This is a master protocol consisting of a core protocol with multiple independent substudies, investigating GSK3377794 treatment in previously untreated (1L) Human Leukocyte Antigen (HLA)-A*02+ participants with NY-ESO1+ advanced metastatic or unresectable synovial sarcoma (Substudy 1) and GSK3377794 as second line or higher (2L+) treatment HLA-A*02+ participants with NY-ESO-1+ advanced metastatic or unresectable synovial sarcoma who have progressed following treatment with anthracycline based chemotherapy (Substudy 2).

View this trial on ClinicalTrials.gov