Clinical Trials

Inclusion Criteria:

• Participant must be ≥ 18 years of age on the day of signing informed consent.
• Participant must be positive for Human leukocyte antigen (HLA)-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles.
• Participant's tumor is positive for NY-ESO-1 expression by a designated central 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
• Participant has advanced (metastatic or unresectable) synovial sarcoma confirmed by histology.
• Participant has received/completed treatment with anthracycline or anthracycline with ifosfamide for advanced (metastatic or inoperable) 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 cell death ligand 1 (PD-L1) checkpoint blockade therapy and doublet taxane & platinum chemotherapy.

Exclusion Criteria:

• Central nervous system metastases, except in rare cases of NSCLC as specified in the protocol.
• 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 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.
• Major surgery ≤ 28 days of first dose of study intervention.
• For participants with NSCLC that harbors an actionable genetic aberration; e.g. BRAF, anaplastic lymphoma kinase (ALK)/ c-ros oncogene 1 (ROS1) or others, has received and failed ≥ 3 lines of systemic therapy.

Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.