Trial Title:
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
NCT ID:
NCT05993299
Condition:
Neoplasms
Conditions: Official terms:
Liposarcoma
Sarcoma, Synovial
Liposarcoma, Myxoid
Cyclophosphamide
Fludarabine
Conditions: Keywords:
Adoptive T-cell therapy
Letetresgene autoleucel
Lete-cel
GSK3377794
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Letetresgene autoleucel
Description:
Letetresgene autoleucel will be administered.
Arm group label:
Letetresgene autoleucel
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide will be used as a lymphodepleting chemotherapy.
Arm group label:
Letetresgene autoleucel
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Fludarabine will be used as a lymphodepleting chemotherapy.
Arm group label:
Letetresgene autoleucel
Summary:
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in
participants with advanced tumors. This trial is a sub study of the Master study
NCT03967223.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
10 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Stanford Hospital and Clinics
Address:
City:
Stanford
Zip:
94305
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Facility:
Name:
Mayo Clinic Jacksonville
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Facility:
Name:
University of Iowa College of Medicine
Address:
City:
Iowa City
Zip:
52242-1009
Country:
United States
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
University of Michigan Medical Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Minnesota Oncology Hematology
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Memorial Sloan Kettering cancer center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
Ohio State University-Columbus
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
University of Pittsburgh, Hillman Cancer centre
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
University Of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-8565
Country:
United States
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-9063
Country:
United States
Facility:
Name:
University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Facility:
Name:
Fred Hutchinson Cancer Research Center
Address:
City:
Seattle
Zip:
98109-1024
Country:
United States
Facility:
Name:
Froedtert Hospital
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Facility:
Name:
CIUSSS de L'Est-De-Lile-De-Montreal
Address:
City:
Montreal
Zip:
H1T 2M4
Country:
Canada
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon cedex
Zip:
69373
Country:
France
Facility:
Name:
CHU de Bordeaux GH Sud Hôpital Haut Lévêque
Address:
City:
Pessac, Cedex
Zip:
33604
Country:
France
Facility:
Name:
Fondazione IRCCS Instituto Nazionale Dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Ircss Istituto Clinico Humanitas
Address:
City:
Romano Di Lombardia
Zip:
20089
Country:
Italy
Facility:
Name:
The Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Facility:
Name:
Hospital Santa Creu Y Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Facility:
Name:
Ico Duran y Reynals l'Hospitalet de Llobrega
Address:
City:
Hospitalet de Llobregat, Barcelona
Zip:
08907
Country:
Spain
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Facility:
Name:
University College Hospital-London
Address:
City:
London
Zip:
WC1E 6AG
Country:
United Kingdom
Facility:
Name:
Christie Hospital NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Start date:
December 31, 2019
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Adaptimmune
Agency class:
Industry
Source:
Adaptimmune
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05993299
