CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.

Exclusion Criteria:

* There are no exclusion criteria for this study

主要终点：Percentage of participants with targeted adverse events (AEs) · From infusion up to 15 years；Percentage of participants with detectable CAR transgene levels in peripheral blood · From infusion up to 15 years；Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy · From infusion up to 15 years；Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies · From infusion up to 15 years；Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood · From infusion up to 15 years；Percentage of participants who died with causes · From infusion up to 15 years
次要终点：Percentage of participants with disease progression；Time to subsequent anticancer therapy；Overall survival

• Previously treated participants with GLPG CAR T-cell therapy · EXPERIMENTAL · All participants who have been treated with a Galapagos CAR T-cell therapy

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.