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
Galapagos NV
546 participants
Sep 9, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
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Interventions
No investigational products will be administered to participants in this study.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06652633