NCT03628612

Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells

Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Autolus Limited · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.

Detailed description

The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.

Conditions

• Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy
• Multiple Myeloma
• DLBCL
• ALL, Adult and Pediatric
• T Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	AUTO CAR T cell therapy	No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.

Timeline

• Start date: 2018-08-02
• Primary completion: 2043-07-01
• Completion: 2043-12-01
• First posted: 2018-08-14
• Last updated: 2025-08-07

Locations

8 sites across 2 countries: United States, United Kingdom