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)

Who is this study for? Child to adult patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Status: Active, not recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: No
View:

• 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.

Locations
United States
California
GSK Investigational Site
Duarte
GSK Investigational Site
Stanford
Colorado
GSK Investigational Site
Denver
Florida
GSK Investigational Site
Jacksonville
Iowa
GSK Investigational Site
Iowa City
Illinois
GSK Investigational Site
Chicago
Massachusetts
GSK Investigational Site
Boston
Michigan
GSK Investigational Site
Ann Arbor
Minnesota
GSK Investigational Site
Minneapolis
GSK Investigational Site
Rochester
Missouri
GSK Investigational Site
Saint Louis
North Carolina
GSK Investigational Site
Durham
New York
GSK Investigational Site
New York
Ohio
GSK Investigational Site
Columbus
Oregon
GSK Investigational Site
Portland
Pennsylvania
GSK Investigational Site
Pittsburgh
Tennessee
GSK Investigational Site
Nashville
Texas
GSK Investigational Site
Dallas
Utah
GSK Investigational Site
Salt Lake City
Virginia
GSK Investigational Site
Richmond
Washington
GSK Investigational Site
Seattle
Wisconsin
GSK Investigational Site
Milwaukee
Other Locations
Canada
GSK Investigational Site
Montreal
GSK Investigational Site
Toronto
France
GSK Investigational Site
Lyon Cedex 08
GSK Investigational Site
Pessac Cedex
Italy
GSK Investigational Site
Milano
GSK Investigational Site
Rozzano (mi)
Netherlands
GSK Investigational Site
Amsterdam
Spain
GSK Investigational Site
Barcelona
GSK Investigational Site
Hospitalet De Llobregat, Barcelona
GSK Investigational Site
Madrid
GSK Investigational Site
Sevilla
United Kingdom
GSK Investigational Site
London
GSK Investigational Site
London
GSK Investigational Site
Manchester
Time Frame
Start Date: December 31, 2019
Estimated Completion Date: July 31, 2026
Participants
Target number of participants: 103
Treatments
Experimental: Substudy 1: lete-cel in previously untreated advanced (metastatic or unresectable) SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T cells. Participants will then receive letetresgene autoleucel.
Experimental: Substudy 2: lete-cel in advanced (metastatic or unresectable) SS or MRCLS post anthracycline chemo
Eligible participants will be leukapheresed to manufacture engineered T cells. Participants will then receive letetresgene autoleucel.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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