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.
All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
There are no exclusion criteria for this study
Single group
GLPG CAR T-cell therapy
GeneticNo investigational products will be administered to participants in this study.
Percentage of participants with targeted adverse events (AEs)
Percentage of participants with detectable CAR transgene levels in peripheral blood
Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy
Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies
Percentage of participants with disease progression
Time to subsequent anticancer therapy
Overall survival
Click on the lead sponsor to view all of their trials.
