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Clinical Trials in Spain / NCT03967223
Active, not recruiting Phase 2

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

NCT03967223 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2019-12-31
Last updated
2026-08-11

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

Letetresgene autoleucel (lete-cel, GSK3377794)Fludarabine →Cyclophosphamide →

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

Sex
ALL
Min age
10 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant must be greater than or equal to 10 years of age on the day of signing informed consent. * Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg * 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. * Male or female. Contraception requirements will apply at the time of leukapheresis and treatment. * 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 (Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant's ability to tolerate protocol therapy or significantly increase the risk of complications). * 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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
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 Spain

Other trials for the same condition

Official registry record

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 Spain