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)
Trial Description
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in
participants with advanced tumors.
Eligibility Requirements
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-A*02:06 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:
- Central nervous system metastases.
- Any other prior malignancy that is not in complete remission.
- 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.
- Previous treatment with genetically engineered NY-ESO-1-specific T cells.
- Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
- Prior gene therapy using an integrating vector.
- Previous allogeneic hematopoietic stem cell transplant.
- Washout periods for prior radiotherapy and systemic chemotherapy must be followed.
- Participant had major surgery in less than or equal to 28 days of first dose of study
intervention.
- Prior radiation exceeds protocol specified limits.