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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391778
• Other study ID #: 208750
• Secondary ID: ADP-0000-002
• Status: Recruiting
• Phase: Phase 1
• Start date: April 9, 2018
• Est. completion date: April 1, 2032

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2032
• Est. primary completion date: April 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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• Participants who have completed GSK sponsored or supported interventional study or have withdrawn from it.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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Biological:
• GSK adoptive cell therapy
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.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Melbourne	Victoria
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Italy	GSK Investigational Site	Milano	Lombardia
Netherlands	GSK Investigational Site	Amsterdam
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Sevilla
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Sutton
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)	AEs will be collected.	15 years post last treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of deaths	Number of deaths will be summarized.	15 years
Secondary	Time to death	Time to death will be summarized.	15 years