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Title
Status

 

IGNYTE-ESO - 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)

Closed to enrollment

IGNYTE-ESO - 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)

Go to Health Care Provider version

DiagnosisAdvanced tumorsStudy StatusClosed to enrollment
PhaseII
Age10 Years and olderRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Letetresgene autoleucel (lete-cel, GSK3377794) letetresgene autoleucel will be administered. Drug: Fludarabine Fludarabine will be used as the lymphodepleting chemotherapy Drug: Cyclophosphamide Cyclophosphamide will be used as the lymphodepleting chemotherapy.
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03967223
International Sponsor
GlaxoSmithKline
Principal Investigators for Canadian Sites
Maisonneuve-Rosemont Hospital
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

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

Inclusion Criteria
  • Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
  • Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
  • Participant should be up and about 60% of their waking hours with minimal to no restrictions 
  • Participant must meet the lab and organ function requirements prior to starting study

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team