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

Official Title

Long-Term Follow-Up (LTFU) of Participants Treated With GSK Adoptive Cell Therapies

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.

Trial Description

Primary Outcome:

  • Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome:
  • Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
  • Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.
  • Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
  • Number of deaths
  • Time to death
Participants who received a GSK adoptive cell therapy will be enrolled in this non-therapeutic, multi-centre, 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society