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

Not Recruiting

Trial ID: NCT03967223


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)

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)


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

   - Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma

   - 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

   - Prior radiation exceeds protocol specified limits.


drug: Fludarabine

drug: Cyclophosphamide

drug: letetresgene autoleucel (lete-cel, GSK3377794)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Montes

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