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 (IGNYTE-ESO)
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- STATUS
- Recruiting
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- End date
- Jul 31, 2026
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- participants needed
- 97
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- sponsor
- GlaxoSmithKline
Summary
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
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)-A02+ 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-A02+ participants with NY-ESO-1+ advanced (metastatic or unresectable) SS or MRCLS who have progressed following treatment with anthracycline based chemotherapy (Substudy 2).
Details
| Condition | Neoplasms |
|---|---|
| Treatment | cyclophosphamide, Fludarabine, GSK3377794, letetresgene autoleucel, letetresgene autoleucel (lete-cel, GSK3377794) |
| Clinical Study Identifier | NCT03967223 |
| Sponsor | GlaxoSmithKline |
| Last Modified on | 26 March 2022 |
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