Study Stopped
The study was terminated due to a change in GSK's R\&D priorities.
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
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
2 other identifiers
interventional
12
6 countries
17
Brief Summary
This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2020
Typical duration for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2023
CompletedResults Posted
Study results publicly available
May 10, 2024
CompletedNovember 26, 2024
November 1, 2024
2.5 years
August 21, 2020
December 1, 2023
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Enrolled Across Sub Studies
Number of Participants Randomized across sub studies are presented.
Day -7
Study Arms (4)
Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC
EXPERIMENTALEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS
EXPERIMENTALEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
EXPERIMENTALEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS
EXPERIMENTALEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
Interventions
GSK3901961 as an IV infusion.
GSK3845097 as an IV infusion.
GSK4427296 as an IV infusion.
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adaptimmunelead
Study Sites (17)
GSK Investigational Site
Jacksonville, Florida, 32224, United States
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Westwood, Kansas, 66205, United States
GSK Investigational Site
Lexington, Kentucky, 40536, United States
GSK Investigational Site
Baltimore, Maryland, 21287, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
New York, New York, 10065, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Melbourne, Victoria, 3000, Australia
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Montreal, Quebec, H1T 2M4, Canada
GSK Investigational Site
Munich, Bavaria, 81377, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Amsterdam, 1066 CX, Netherlands
GSK Investigational Site
Stockholm, SE-171 64, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- PRINCIPAL INVESTIGATOR
Adaptimmune Patient Enquiries
Adaptimmune
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- This will be an open-label study. Hence, there will be no masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 25, 2020
Study Start
December 21, 2020
Primary Completion
June 8, 2023
Study Completion
June 8, 2023
Last Updated
November 26, 2024
Results First Posted
May 10, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.