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

  • End date
    Feb 13, 2024
  • participants needed
  • sponsor
Updated on 3 May 2022
primary cancer
targeted therapy


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


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).

Condition Neoplasms
Treatment cyclophosphamide, Fludarabine, GSK3901961, GSK3845097, GSK4427296
Clinical Study IdentifierNCT04526509
Last Modified on3 May 2022


Yes No Not Sure

Inclusion Criteria

Participant must be >=18 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
Participant's tumor must have tested positive for NY-ESO-1/ LAGE-1a expression by a GSK designated laboratory
Performance status: Eastern Cooperative Oncology Group of 0-1
Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis
Participant must have measurable disease according to RECIST v1.1
Additional criteria for participants with synovial sarcoma/ MRCLS
Participant has advanced (metastatic or unresectable) synovial sarcoma or MRCLS confirmed by local histopathology with evidence of disease-specific translocation
Participant has received/completed treatment with anthracycline or with ifosfamide if intolerant to anthracycline for advanced (metastatic or unresectable) disease and progressed
Additional criteria for participants with non-small cell lung cancer (NSCLC)
Participant has Stage IV NSCLC as confirmed by histology or cytology
Participant has been previously treated with or is intolerant to programmed death receptor-1 (PD)-1/Programmed death ligand 1 (PD-L1) checkpoint blockade therapy. For NSCLC that harbors an actionable genetic aberration (BRAF, anaplastic lymphoma kinase [ALK]/ c-ros oncogene 1 [ROS1]) per National Comprehensive Cancer Network (NCCN) guidelines, participant has also been previously treated with or is intolerant to the standard of care targeted therapy as recommended by NCCN or equivalent country-level guidelines (European Society for Medical Oncology [ESMO], National Institute for Health & Care Excellence [NICE])

Exclusion Criteria

Any other prior malignancy that is not in complete remission
Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in NSCLC as specified in the protocol
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 requiring steroids or other immunosuppressive treatments
Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1 vaccine or NY-ESO-1 targeting antibody
Prior gene therapy using an integrating vector
Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant
Washout periods for prior radiotherapy and systemic chemotherapy must be followed
Major surgery within 4 weeks prior to lymphodepletion
Pregnant or breastfeeding females
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