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

PHASE1RECRUITING

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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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.

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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Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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 : 0 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2018-04-09

Primary completion: 2032-04-01

Study completion finish: 2032-04-01

Study type

OTHER

Phase

PHASE1

Trial ID

NCT03391778

Intervention or treatment

BIOLOGICAL: ADP adoptive cell therapy

Conditions

• Neoplasms

Condition: Neoplasms
BIOLOGICAL: ADP adoptive cell therapy
Melbourne, Victoria, Australia
Sponsor: Adaptimmune

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Peter MacCallum Cancer Centre

Research sites nearby

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Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

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 Not Specified	BIOLOGICAL: ADP adoptive cell therapy 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Adoptive Cell Therapy Long-term Follow-up (LTFU) Study