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 scheduled to receive clinical drug product supply must also weigh ≥40 kg

   - 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.

   - Male or female. Contraception requirements will apply at the time of leukapheresis and

   - 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 (Serious active infections or significant
   cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the
   Investigator would compromise the participant's ability to tolerate protocol therapy
   or significantly increase the risk of complications).

   - 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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