Skip to main content

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 Status: Active

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

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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Massachusetts

Boston
Boston Children's Hospital
Status: CLOSED_TO_ACCRUAL
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE
Rochester
Mayo Clinic in Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Sandra Pierina D'Angelo
Phone: 646-888-4159

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Caryn R. Weir
Phone: 804-628-2310
Email: cweir@vcu.edu

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins

that have been found in several tumor types. Clinical trials using adoptively transferred T

cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene

autoleucel (lete-cel, GSK3377794) is the first generation of NY-ESO-1 specific T-cell

receptor engineered T cells. This is a master protocol investigating T-cell therapies. It

will initially consist of a core protocol with two independent substudies investigating

Letetresgene autoleucel in previously untreated (1L) Human Leukocyte Antigen (HLA)-A*02+

participants with NY-ESO-1+ advanced (metastatic or unresectable) synovial sarcoma (SS) or

myxoid/round cell liposarcoma (MRCLS) (Substudy 1) and Letetresgene autoleucel as second line

or higher (2L+) treatment in HLA-A*02+ participants with NY-ESO-1+ advanced (metastatic or

unresectable) SS or MRCLS who have progressed following treatment with anthracycline based

chemotherapy (Substudy 2).

Trial Phase Phase II

Trial Type Treatment

Lead Organization
GlaxoSmithKline

  • Primary ID 208467
  • Secondary IDs NCI-2019-05288
  • Clinicaltrials.gov ID NCT03967223