Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

Sponsor: Lakefront Biotherapeutics NV

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06652633

Patient View

This study monitors long-term safety and efficacy of GLPG CAR T-cell therapies over 15 years, focusing on delayed adverse events, benefit/risk profile, RCL, and CAR-T cell persistence. Eligible participants include those previously treated in clinical trials or Managed Access Programs. No new investigational products will be administered.

Patient Parameters

Program Overview

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

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.