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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-Term Follow-Up (LTFU) of Participants Treated With GSK Adoptive Cell Therapies

Conditions
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Neoplasms

Intervention / Treatment
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* Biological: GSK adoptive cell therapy


Participation Criteria
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Eligibility Criteria
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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 Participants who have completed GSK sponsored or supported interventional study or have withdrawn from it.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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving GSK adoptive cell therapy<br> | Biological: GSK adoptive cell therapy<br>* No study drug is administered in this study. Participants who received GSK adoptive cell therapy in a previous trial will be evaluated in this trial for long-term safety and efficacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long Term Follow Up, Adoptive Cell Therapy, Replication Competent Lentivirus