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

Trial ID or NCT#

NCT03967223

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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)

Eligibility Criteria

Ages Eligible for Study: Older than 10 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo
Sarcoma specialist, Medical oncologist
Professor of Medicine (Oncology)

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Contact

Denise Montes
650-725-4185