Neoplasms
Conditions
Keywords
Long Term Follow Up, Adoptive Cell Therapy, Replication Competent Lentivirus
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALADP 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.
Sponsors
USWM CT, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 * Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) | 15 years post last treatment | AEs will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples | 15 years | Peripheral blood samples will be collected for the assessment of VSV-G DNA copies. |
| Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples. | 15 years | Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA. |
| Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples | 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). |
| Number of deaths | 15 years | Number of deaths will be summarized. |
| Time to death | 15 years | Time to death will be summarized. |
Countries
Australia, Canada, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORMichael Nathenson, MD
USWM CT, LLC
Outcome results
None listed