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NCT Number: NCT03391778

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

This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.

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Key information

Conditions

Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

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About this study

Participants who received a ADP 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who have received at least one dose of ADP adoptive cell therapy agent.
  • Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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

Treatment and study plan

ADP adoptive cell therapy

Biological

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

Primary outcomes

  1. Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 15 years post last treatment

    AEs will be collected.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Investigator Study Inquiries LTFU

CONTACT

[email protected]

866-750-8796

Sponsors and collaborators

Lead sponsor

USWM CT, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2032
Study completion
2032
First posted
Jan 5, 2018
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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