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 Tumours

Official Title

Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumours


This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumours.

Trial Description

Primary Outcome:

  • Substudy 1 and 2: Frequency of dose limiting toxicities (DLTs) according to severity.
  • Substudy 1 and 2:Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity
Secondary Outcome:
  • Substudy 1 and 2: Overall response rate (ORR)
  • Substudy 1 and 2: Duration of response (DOR)
  • Substudy 1 and 2: Maximum expansion/persistence (Cmax)
  • Substudy 1 and 2: Time to Cmax (Tmax)
  • Substudy 1 and 2: Area under the concentration/persistence time curve from zero to time t (AUC[0-t])
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 have shown objective responses. GSK3901961 and GSK3845097 are next generation engineered T-cell receptor (TCR) T-cells, co-expressing the CD8α cell surface receptor, targeting NY-ESO-1, and co-expressing the dnTGF-beta 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-A*02+ participants with NYESO1+ previously treated advanced (metastatic or unresectable) synovial sarcoma (SS) and/or previously treated metastatic non-small cell lung cancer (NSCLC).

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society