Clinical Trial 21956

• Overview

  Study Title:

  Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

  Summary:

  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.

  Objective:

  Primary: Describe selected, delayed AEs that are suspected to be related to previous CAR T-cell therapy as outlined in current Health Authority guidelines. Secondary: Monitor the persistence of modified T-cells in peripheral blood Monitor for RCL (Replication Competent Lentivirus) Assess the longterm efficacy of CAR-T Monitor lymphocyte levels Describe the growth, development, and female reproductive status for patients who were aged < 18 years at the time of the initial CAR-T infusion

• Inclusion Criteria

  Key Inclusion Criteria:
  • All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
  • Patients who have provided informed consent for the long term follow up study prior to their study participation.

• Exclusion Criteria

  Key Exclusion Criteria:
  • There are no specific exclusion criteria for this study.

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