Last updated: 10/28/2022 06:43:15
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid TumorsIGNYTE-ESO
GSK study ID
208467
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Active, not recruiting
Active, not recruiting
Trial overview
Official title: 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)
Trial description: This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Substudy 1: Overall response rate (ORR)
Timeframe: Until disease progression (up to 5 years)
Substudy 2: Overall response rate (ORR) as assessed by central independent review
Timeframe: Up to 5 years
Secondary outcomes:
Substudy 1 and 2: Time to response (TTR)
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Duration of response (DOR)
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Disease control rate (DCR)
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Progression free survival (PFS)
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Number of participants with replication competent lentivirus (RCL)
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Number of participants with insertional oncogenesis (IO)
Timeframe: Until disease progression (up to 5 years)
Substudy 2: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis parameters
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Maximum transgene expansion (Cmax) of letetresgene autoleucel
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Time to Cmax (Tmax) of letetresgene autoleucel
Timeframe: Until disease progression (up to 5 years)
Substudy 1 and 2: Area under the concentration/persistence time curve from zero to time t (AUC[0-t]) of letetresgene autoleucel
Timeframe: Until disease progression (up to 5 years)
Substudy 2: Overall response rate (ORR) as determined by the local investigators
Timeframe: Up to 5 years
Substudy 2: Overall Survival (OS)
Timeframe: Up to 5 years
Substudy 2: Number of participants with positive anti-drug antibodies (ADA) and titers of ADA against letetresgene autoleucel
Timeframe: Up to 36 months
Interventions:
Drug: Letetresgene autoleucel (lete-cel, GSK3377794)
Drug: Fludarabine
Drug: Cyclophosphamide
Enrollment:
103
Observational study model:
Not applicable
Primary completion date:
2022-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms
Product
GSK3377794
Collaborators
Not applicable
Study date(s)
December 2019 to July 2026
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
10+ years
Accepts healthy volunteers
No
- Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
- 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
- Central nervous system metastases.
- Any other prior malignancy that is not in complete remission.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
- 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.
- 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.
- 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.
Trial location(s)
Location
GSK Investigational Site
Duarte, California, United States, 91010
Status
Recruitment Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Recruitment Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Recruitment Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Status
Recruitment Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Recruitment Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-9063
Status
Recruitment Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H1T 2M4
Status
Recruitment Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84112
Status
Recruitment Complete
Location
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Status
Recruitment Complete
Location
GSK Investigational Site
Iowa City, Iowa, United States, 52242-1009
Status
Recruitment Complete
Location
GSK Investigational Site
Stanford, California, United States, 94305
Status
Recruitment Complete
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Recruitment Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Status
Recruitment Complete
Location
GSK Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Status
Recruitment Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Recruitment Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Recruitment Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Recruitment Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Recruitment Complete
Location
GSK Investigational Site
London, United Kingdom, WC1E 6AG
Status
Recruitment Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Recruitment Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Recruitment Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23298
Status
Recruitment Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Recruitment Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Recruitment Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98109-1024
Status
Recruitment Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Active, not recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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