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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2032
  • participants needed
    250
  • sponsor
    GlaxoSmithKline
Updated on 24 March 2022
primary cancer

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.

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.

Details
Condition Neoplasms
Treatment GSK3377794 (NY-ESO-1ᶜ²⁵⁹ T), GSK adoptive cell therapy
Clinical Study IdentifierNCT03391778
SponsorGlaxoSmithKline
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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Participants who have completed GSK sponsored or supported interventional study or have withdrawn from it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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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