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Long Term Follow-Up of Subjects Exposed to GSK3377794

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ClinicalTrials.gov Identifier: NCT03391778
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

Condition or disease Intervention/treatment Phase
Neoplasms Genetic: GSK3377794 (NY-ESO-1ᶜ²⁵⁹ T) Phase 1

Detailed Description:
This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1ᶜ²⁵⁹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : April 1, 2032
Estimated Study Completion Date : April 1, 2032

Arm Intervention/treatment
Experimental: GSK3377794
Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1ᶜ²⁵⁹T in a previous trial
Genetic: GSK3377794 (NY-ESO-1ᶜ²⁵⁹ T)
No study drug is administered in this study. Subjects who received NY-ESO-1ᶜ²⁵⁹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.




Primary Outcome Measures :
  1. Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors [ Time Frame: 15 years post last treatment ]

    The following AEs will be reported:

    • New malignancies
    • New incidence or exacerbation of a pre-existing neurologic disorder
    • New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
    • New incidence of immune-related hematologic disorder
    • Serious infections (including opportunistic)
    • Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy


Secondary Outcome Measures :
  1. Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies [ Time Frame: 15 years ]
    Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.

  2. Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies [ Time Frame: 15 years ]
    The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.

  3. Number of subjects with integrated vector sequences and vector integration patterns [ Time Frame: 15 years ]
    Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.

  4. Number of deaths [ Time Frame: 15 years ]
    Number of deaths will be summarized.

  5. Time to death [ Time Frame: 15 years ]
    Time to death will be summarized.



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have received at least one dose of GSK3377794 in the interventional study.
  • Subjects who have either completed the interventional study or have withdrawn from it.
  • Male or Female subjects.
  • Capable of giving signed informed consent prior to the study participation.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391778


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
Duarte, California, United States, 91010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Warren Chow         
United States, Colorado
GSK Investigational Site Recruiting
Denver, Colorado, United States, 80218
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Shiraj Sen         
United States, Florida
GSK Investigational Site Recruiting
Miami, Florida, United States, 33136
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gilberto Lopes         
GSK Investigational Site Recruiting
Tampa, Florida, United States, 33612
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mihaela Druta         
United States, Georgia
GSK Investigational Site Recruiting
Atlanta, Georgia, United States, 30322
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jonathan Kaufman         
United States, Kentucky
GSK Investigational Site Recruiting
Lexington, Kentucky, United States, 40536
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: John Villano         
United States, Maryland
GSK Investigational Site Recruiting
Baltimore, Maryland, United States, 21201
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Aaron Rapoport         
GSK Investigational Site Recruiting
Bethesda, Maryland, United States, 20892
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: John Glod         
United States, Massachusetts
GSK Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: George D Demetri         
United States, Missouri
GSK Investigational Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Brian Van Tine         
United States, New York
GSK Investigational Site Recruiting
New York, New York, United States, 10065
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sandra P D'Angelo         
United States, Ohio
GSK Investigational Site Recruiting
Columbus, Ohio, United States, 43210
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David Liebner         
United States, Pennsylvania
GSK Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Edward A Stadtmauer         
GSK Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Liza Villaruz         
United States, Tennessee
GSK Investigational Site Recruiting
Nashville, Tennessee, United States, 37203
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Melissa L Johnson         
United States, Texas
GSK Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dejka Araujo         
Canada, Ontario
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Adrian Sacher         
Canada, Quebec
GSK Investigational Site Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Simon Turcotte         
Spain
GSK Investigational Site Recruiting
Barcelona, Spain, 08035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Enriqueta Felip         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03391778    
Other Study ID Numbers: 208750
ADP-0000-002 ( Other Identifier: Adaptimmune Therapeutics )
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Genetically engineered
Immuno-oncology
T Cell Therapy
T Cell Receptor
Previously Treated
Cell Therapy
SPEAR T Cell
Metastatic
Solid and Hematological Malignancies
Safety
Long Term Follow Up
NY-ESO-1