Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
Start Date
9/9/2024
Completion Date
7/1/2039
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 Criteria
Age Range: 18 years to No maximum
Interventions
GLPG CAR T-cell therapy
Conditions
Locations
Tufts Medical Center
Boston, Massachusetts 02111
United States
Antwerp University Hospital
Edegem, 2650
Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
Centre Hospitalier Universitaire (CHU) De Liège
Liège, 4032
Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800
Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
Belgium
helsingin yliopistollinen sairaala comprehensive cancer center (HUS)
Helsinki, 00290
Finland
Academisch Medisch Centrum (Amsterdam UMC)
Amsterdam, 1105 AZ
Netherlands
Leids University Medical Center (LUMC)
Leiden, 2333 ZA
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015
Netherlands
Hospital Clinic De Barcelona
Barcelona, 08036
Spain