Master Protocol to Assess 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

Active:	No
Cancer Type:	Lung Cancer Sarcoma Solid Tumor Unknown Primary	NCT ID:	NCT04526509
Trial Phases:	Phase I	Protocol IDs:	209012 (primary) NCI-2020-11491
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	GlaxoSmithKline
NCI Full Details:	http://clinicaltrials.gov/show/NCT04526509

Summary

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

Objectives

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, GSK3845097 and
GSK4427296 are next generation engineered T-cell receptor (TCR) T-cells, co-expressing the
cluster of differentiation 8 (CD8) alpha cell surface receptor, targeting NY-ESO-1,
co-expressing the dominant-negative TGF-beta receptor type II (dnTGF-beta RII) cell surface
receptor, targeting NY-ESO-1, and engineered using the Epigenetically Reprogrammed (Epi-R)
manufacturing process, respectively to potentially improve function. This is a master
protocol evaluating first time in human T-cell therapies. It currently consists of three
independent substudies, investigating GSK3901961, GSK3845097 and GSK4427296 in human
leukocyte antigen (HLA)-A*02 positive participants with NYESO1+ previously treated advanced
(metastatic or unresectable) synovial sarcoma (SS)/myxoid/round cell liposarcoma (MRCLS)
and/or previously treated metastatic non-small cell lung cancer (NSCLC).

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