Last updated: 07/17/2024 17:54:18

Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors

GSK study ID
209012
Clinicaltrials.gov ID
NCT04526509
See results summary
EudraCT ID
2019-004446-14
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 Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, alone or in combination with other agents, in Participants with Advanced Tumors
Trial description: This trial will evaluate the safety and efficacy of first time in 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, 2 and 3: Frequency of dose limiting toxicities (DLTs)

Timeframe: Until disease progression (up to 4 years)

Substudy 1, 2 and 3:Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity

Timeframe: Until disease progression (up to 4 years)

Secondary outcomes:

Substudy 1, 2 and 3: Overall response rate (ORR)

Timeframe: Until disease progression (up to 4 years)

Substudy 1, 2 and 3: Duration of response (DOR)

Timeframe: Until disease progression (up to 4 years)

Substudy 1, 2 and 3: Maximum expansion/persistence (Cmax)

Timeframe: Until disease progression (up to 4 years)

Substudy 1, 2 and 3 : Time to Cmax (Tmax)

Timeframe: Until disease progression (up to 4 years)

Substudy 1, 2 and 3: Area under the concentration/persistence time curve from zero to time t (AUC[0-t])

Timeframe: Until disease progression (up to 4 years)

Interventions:
  • Drug: GSK3901961
  • Drug: GSK3845097
  • Drug: GSK4427296
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
    • Enrollment:
    11
    Primary completion date:
    2025-04-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2020 to December 2025
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Eligibility Criteria:
    • Inclusion criteria:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Eligibility Criteria: Inclusion criteria:
    • Participant must be >=18 years of age and weighs ≥40 kg 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
    • Participant’s tumor must have tested positive for NY-ESO-1 and/or LAGE-1a expression by a GSK designated laboratory
    • Performance status: Eastern Cooperative Oncology Group of 0-1
    • Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis
    • Participant must have measurable disease according to RECIST v1.1. Additional criteria for participants with SS/ MRCLS:
    • Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local histopathology with evidence of disease-specific translocation
    • Participant has completed at least one standard of care (SOC) treatment including anthracycline containing regimen unless intolerant to or ineligible to receive the therapy. Participants who are not candidates to receive anthracycline should have received ifosfamide unless also intolerant to or ineligible to receive ifosfamide. Participants who received neoadjuvant/adjuvant anthracycline or ifosfamide based therapy and progressed will be eligible Additional criteria for participants with non-small cell lung cancer (NSCLC):
    • Participant has Stage IV NSCLC as confirmed by histology or cytology
    • Prior therapies for participants lacking actionable genetic aberrations (i.e., wild type), per National Comprehensive Cancer Network (NCCN) guidelines: participant has been previously treated with or is intolerant to programmed death receptor-1 (PD)-1/Programmed death ligand 1 (PD-L1) checkpoint blockade therapy and has been previously treated with or is intolerant to a platinum-based chemotherapy. Adjuvant therapy will count as a regimen if completed within 6 months before relapse. Or for participants that harbors an actionable genetic aberration (e.g. BRAF, anaplastic lymphoma kinase [ALK]/ c-ros oncogene 1 [ROS1] etc.), per NCCN guidelines: participants has been previously treated with or is intolerant to SOC therapy, including targeted therapy, as recommended by NCCN or equivalent country-level guidelines (European Society for Medical Oncology [ESMO], National Institute for Health & Care Excellence [NICE]) . Or Investigator has decided that additional lines of SOC therapy after the first line are not in the participant’s best interest. Exclusion criteria:
    • Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in NSCLC as specified in the protocol
    • 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 requiring steroids or other immunosuppressive treatments
    • Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1 vaccine or NY-ESO-1 targeting antibody
    • Prior gene therapy using an integrating vector
    • Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant
    • Washout periods for prior radiotherapy and systemic chemotherapy must be followed
    • Major surgery within 4 weeks prior to lymphodepletion
    • Pregnant or breastfeeding females

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30322
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40536
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H1T 2M4
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10065
    Status
    Recruitment Complete
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    Showing 1 - 6 of 21 Results

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    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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