Long Term Follow-Up of Patients Exposed to Lentiviral- Based CD19 directed CART Cell Therapy
MD Anderson Study Status
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 patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.
Information and next steps
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
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