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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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- Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
OTHER
Phase
- PHASE1
Study ID
NCT03391778
Intervention or treatment
BIOLOGICAL: ADP adoptive cell therapy
Conditions
- Neoplasms
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Peter MacCallum Cancer Centre
Select from list below to view details:
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Adaptimmune
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Participants receiving ADP adoptive cell therapy
| Biological: ADP adoptive cell therapy |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) | AEs will be collected. | 15 years post last treatment |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples | Peripheral blood samples will be collected for the assessment of VSV-G DNA copies. | 15 years |
| Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples. | Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA. | 15 years |
| Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples | Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal). | 15 years |
| Number of deaths | Number of deaths will be summarized. | 15 years |
| Time to death | Time to death will be summarized. | 15 years |
References
Clinical Trials Gov: Adoptive Cell Therapy Long-term Follow-up (LTFU) StudyOther trials to consider
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