NCT03967223

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

Master Protocol to Assess the Safety and Antitumor 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 Tumors (IGNYTE-ESO)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: USWM CT, LLC · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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/LAGE-1a have shown objective responses. Letetresgene autoleucel (lete-cel, GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor engineered T cells. This is a master protocol investigating T-cell therapies. It will initially consist of a core protocol with two independent substudies investigating Letetresgene autoleucel in previously untreated (1L) Human Leukocyte Antigen (HLA)-A\*02+ participants with NY-ESO-1+ advanced (metastatic or unresectable) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS) (Substudy 1) and Letetresgene autoleucel as second line or higher (2L+) treatment in HLA-A\*02+ participants with NY-ESO-1+ advanced (metastatic or unresectable) SS or MRCLS who have progressed following treatment with anthracycline based chemotherapy (Substudy 2).

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Letetresgene autoleucel (lete-cel, GSK3377794)	letetresgene autoleucel will be administered.
DRUG	Fludarabine	Fludarabine will be used as the lymphodepleting chemotherapy
DRUG	Cyclophosphamide	Cyclophosphamide will be used as the lymphodepleting chemotherapy.

Timeline

• Start date: 2019-12-31
• Primary completion: 2024-03-01
• Completion: 2026-07-31
• First posted: 2019-05-30
• Last updated: 2026-04-17

Locations

38 sites across 7 countries: United States, Canada, France, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study