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
NCT ID: NCT04526509
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
12 participants
INTERVENTIONAL
2020-12-21
2023-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
GSK3901961
GSK3901961 as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
GSK3901961
GSK3901961 as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
GSK3845097
GSK3845097 as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
GSK4427296
GSK4427296 as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
Interventions
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GSK3901961
GSK3901961 as an IV infusion.
GSK3845097
GSK3845097 as an IV infusion.
GSK4427296
GSK4427296 as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Adaptimmune
INDUSTRY
Responsible Party
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Principal Investigators
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Adaptimmune Patient Enquiries
Role: PRINCIPAL_INVESTIGATOR
Adaptimmune
Locations
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GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Westwood, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Stockholm, , Sweden
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-004446-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
209012
Identifier Type: -
Identifier Source: org_study_id
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