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
NCT03967223
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2022-30-11
    Observational study model:
    Not applicable
    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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Duarte, California, United States, 91010
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80218
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M5G 2M9
    Status
    Recruitment Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75390-9063
    Status
    Recruitment Complete
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    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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