Adoptive Cell Therapy Long-term Follow-up (LTFU) Study

• ClinicalTrials.gov Identifier: NCT03391778
• Recruitment Status: Recruiting
• First Posted: January 5, 2018
• Last Update Posted: March 30, 2023
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: January 2, 2018
• First Posted Date: January 5, 2018
• Last Update Posted Date: March 30, 2023
• Actual Study Start Date: April 9, 2018
• Estimated Primary Completion Date: April 1, 2032 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 22, 2021)

Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 15 years post last treatment ]

AEs will be collected.

Original Primary Outcome Measures (submitted: January 2, 2018)

Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor [ Time Frame: 15 years post last treatment ]

• 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 a hematologic disorder
• Opportunistic and/or serious infections
• Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy

Current Secondary Outcome Measures (submitted: June 22, 2021)

• Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples [ Time Frame: 15 years ]
  Peripheral blood samples will be collected for the assessment of VSV-G DNA copies.
• Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples. [ Time Frame: 15 years ]
  Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA.
• Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples [ Time Frame: 15 years ]
  Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal).
• Number of deaths [ Time Frame: 15 years ]
  Number of deaths will be summarized.
• Time to death [ Time Frame: 15 years ]
  Time to death will be summarized.

Original Secondary Outcome Measures (submitted: January 2, 2018)

• Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells [ Time Frame: 15 years post last treatment ]
  Subjects' peripheral blood samples will be used to evaluate RCL
• Persistence of genetically modified cells in the body [ Time Frame: 15 years post last treatment ]
  Peripheral blood samples will be used to evaluate persistence
• Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR [ Time Frame: 15 years post last treatment ]
  Number of samples positive for vector integration by PCR
• Overall Survival (OS) post-infusion [ Time Frame: 15 years post last treatment ]
  OS defined as the interval between the date of first T cell infusion and date of death due to any cause

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
• Official Title: Long-Term Follow-Up (LTFU) of Participants Treated With GSK Adoptive Cell Therapies
• Brief Summary: This trial will evaluate long term safety of participants who have received GlaxoSmithKline (GSK) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.
• Detailed Description: Participants who received a GSK adoptive cell therapy will be enrolled in this non-therapeutic, multi-center, long term follow-up (LTFU) study and will be followed for up to 15 years post-infusion of lentiviral vector-based adoptive cell therapy. Participants will be monitored for safety following last adoptive cell therapy infusion.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Neoplasms

Intervention

Biological: GSK adoptive cell therapy

No study drug is administered in this study. Participants who received GSK adoptive cell therapy in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Study Arms

Experimental: Participants receiving GSK adoptive cell therapy

Intervention: Biological: GSK adoptive cell therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 21, 2020): 250
• Original Estimated Enrollment (submitted: January 2, 2018): 300
• Estimated Study Completion Date: April 1, 2032
• Estimated Primary Completion Date: April 1, 2032 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participants who have received at least one dose of GSK adoptive cell therapy agent.
• Participants who have completed GSK sponsored or supported interventional study or have withdrawn from it.
• Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• The investigator is responsible for review of medical history.
• Capable of giving signed informed consent.

Exclusion Criteria:

- None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Canada, Spain, United Kingdom, United States
• Removed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT03391778
• Other Study ID Numbers: 208750; ADP-0000-002 ( Other Identifier: Adaptimmune Therapeutics )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: 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

• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Adaptimmune
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Adaptimmune
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: March 2023