NCT06652633

Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 546 (estimated)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion. Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
GENETIC	GLPG CAR T-cell therapy	No investigational products will be administered to participants in this study.

Timeline

• Start date: 2024-09-09
• Primary completion: 2039-07-01
• Completion: 2039-07-01
• First posted: 2024-10-22
• Last updated: 2026-02-05

Locations

6 sites across 3 countries: Belgium, Netherlands, Spain