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
Condition(s) studied
Investigational drug(s) / intervention(s)
Letetresgene autoleucel (lete-cel, GSK3377794): letetresgene autoleucel will be administered.
Fludarabine: Fludarabine will be used as the lymphodepleting chemotherapy
Cyclophosphamide: Cyclophosphamide will be used as the lymphodepleting chemotherapy.
Study summary
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
Eligibility
Primary outcome measure(s)
- Substudy 1: Overall response rate (ORR) — Until disease progression (up to 5 years)
Overall response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants within the analysis population at any time per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. as determined by the local investigators. - Substudy 2: Overall response rate (ORR) as assessed by central independent review — Up to 5 years
Overall response rate is defined as the percentage of participants with a confirmed CR or PR relative to the total number of participants within the analysis population at any time per RECIST v1.1. as assessed by central independent review.
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | |
| Stanford Hospital and Clinics | Stanford | California | |
| Sarah Cannon Research Institute | Denver | Colorado | |
| Mayo Clinic Jacksonville | Jacksonville | Florida | |
| University of Chicago | Chicago | Illinois | |
| University of Iowa College of Medicine | Iowa City | Iowa | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| University of Michigan Medical Center | Ann Arbor | Michigan | |
| Minnesota Oncology Hematology | Minneapolis | Minnesota | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| Washington University | St Louis | Missouri | |
| Memorial Sloan Kettering cancer center | New York | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| Ohio State University-Columbus | Columbus | Ohio | |
| Oregon Health and Science University | Portland | Oregon | |
| University of Pittsburgh, Hillman Cancer Centre | Pittsburgh | Pennsylvania | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| University Of Texas Southwestern Medical Center | Dallas | Texas | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| University of Utah | Salt Lake City | Utah | |
| Virginia Commonwealth University | Richmond | Virginia | |
| Fred Hutchinson Cancer Research | Seattle | Washington | |
| Froedtert Hospital | Milwaukee | Wisconsin | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| CIUSSS de L'Est-De-Lile-De-Montreal | Montreal | Quebec | |
| Centre Léon Bérard | Lyon | France | |
| CHU de Bordeaux GH Sud Hôpital Haut Lévêque | Pessac | France | |
| Fondazione IRCCS Instituto Nazionale Dei Tumori | Milan | Lombardy | |
| Ircss Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | |
| The Netherlands Cancer Institute | Amsterdam | Netherlands | |
| Hospital Santa Creu Y Sant Pau | Barcelona | Spain | |
| Ico Duran y Reynals l'Hospitalet de Llobrega | Hospitalet de Llobregat, Barcelona | Spain | |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | |
| Hospital Virgen Del Rocio | Seville | Spain | |
| Royal Marsden Hospital | London | United Kingdom | |
| University College Hospital-London | London | United Kingdom | |
| Christie Hospital NHS Foundation Trust | Manchester | United Kingdom |
More USWM CT, LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03967223 on ClinicalTrials.gov ↗ ← All trials in the USA