Health TrialsbyHealthPanel

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

ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUSWM CT, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • ADP adoptive cell therapy

    Biological/Vaccine

    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.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Participants receiving ADP adoptive cell therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

AEs will be collected.

Time frame
15 years post last treatment

Secondary outcomes

1

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.

Time frame
15 years
2

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.

Time frame
15 years
3

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).

Time frame
15 years
4

Number of deaths

Number of deaths will be summarized.

Time frame
15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

USWM CT, LLC

Lead sponsor

Source ClinicalTrials.gov
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