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)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2026
  • participants needed
    97
  • sponsor
    GlaxoSmithKline
Updated on 26 March 2022
cyclophosphamide
measurable disease
bone marrow procedure
anthracyclines
primary cancer
solid neoplasm
sarcoma

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 IdentifierNCT03967223
SponsorGlaxoSmithKline
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be greater than or equal to 10 years of age on the day of signing informed consent
Participant must be positive for HLA-A _02:01, HLA-A_ 02:05, and/or HLA-A02:06 alleles by a designated central laboratory
Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory
Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
Performance status: dependent on age - Lansky > 60, Karnofsky > 60, Eastern Cooperative Oncology Group 0-1
Participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis
At time of treatment, participant has measurable disease according to RECIST v1.1
Consultation for prior history per protocol specifications

Exclusion Criteria

Clinically significant systemic illness
Prior or active demyelinating disease
History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments
Central nervous system metastases
Washout periods for prior radiotherapy and systemic chemotherapy must be followed
Any other prior malignancy that is not in complete remission
Previous treatment with genetically engineered NY-ESO-1-specific T cells
Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody
Prior radiation exceeds protocol specified limits
Prior gene therapy using an integrating vector
Previous allogeneic hematopoietic stem cell transplant
Participant had major surgery in less than or equal to 28 days of first dose of study intervention
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