Last updated: 02/26/2024 13:50:15
Adoptive cell therapy long-term follow-up (LTFU) study
GSK study ID
208750
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: Long-Term Follow-Up (LTFU) of Participants Treated with GSK Adoptive Cell Therapies
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
Timeframe: 15 years post last treatment
Secondary outcomes:
Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
Timeframe: 15 years
Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.
Timeframe: 15 years
Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
Timeframe: 15 years
Number of deaths
Timeframe: 15 years
Time to death
Timeframe: 15 years
Interventions:
Biological/vaccine: GSK adoptive cell therapy
Enrollment:
250
Observational study model:
Not applicable
Primary completion date:
2032-01-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms
Product
GSK3377794
Collaborators
NA
Study date(s)
April 2018 to April 2032
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- 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- Participants who have completed GSK sponsored or supported interventional study or have withdrawn from it.
- None
Inclusion and exclusion 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- Participants who have completed GSK sponsored or supported interventional study or have withdrawn from it.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
Trial location(s)
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20892
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Recruiting
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Status
Recruiting
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Recruiting
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Recruiting
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
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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