The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab
Official Title: A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination With Pembrolizumab in HLA-A2+ Participants With NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer
Study ID: NCT03709706
Brief Summary: This trial will evaluate safety and tolerability of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with non-small cell lung cancer.
Detailed Description: New York esophageal squamous cell carcinoma-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 (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR) engineered T-cells. This is a multi-arm, open-label study of letetresgene autoleucel (lete-cel, GSK3377794) in Human Leukocyte Antigen (HLA)-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive adults whose tumors express NY-ESO-1 and/or LAGE-1a. This study will enroll participants who have unresectable Stage IIIb or Stage IV NSCLC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Duarte, California, United States
GSK Investigational Site, La Jolla, California, United States
GSK Investigational Site, Sacramento, California, United States
GSK Investigational Site, Stanford, California, United States
GSK Investigational Site, Denver, Colorado, United States
GSK Investigational Site, Hollywood, Florida, United States
GSK Investigational Site, Atlanta, Georgia, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Iowa City, Iowa, United States
GSK Investigational Site, Lexington, Kentucky, United States
GSK Investigational Site, Baltimore, Maryland, United States
GSK Investigational Site, Saint Louis, Missouri, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Durham, North Carolina, United States
GSK Investigational Site, Columbus, Ohio, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Pittsburgh, Pennsylvania, United States
GSK Investigational Site, Nashville, Tennessee, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Salt Lake City, Utah, United States
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Montréal, Quebec, Canada
GSK Investigational Site, Amsterdam, , Netherlands
GSK Investigational Site, Groningen, , Netherlands
GSK Investigational Site, Rotterdam, , Netherlands
GSK Investigational Site, Utrecht, , Netherlands
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Manchester, , United Kingdom
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR