RecruitingPhase 3NCT06652633

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

A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies


Sponsor

Galapagos NV

Enrollment

546 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria1

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICGLPG CAR T-cell therapy

No investigational products will be administered to participants in this study.


Locations(6)

Antwerp University Hospital

Edegem, Belgium

Centre Hospitalier Universitaire (CHU) De Liège

Liège, Belgium

Amsterdam UMC

Amsterdam, Netherlands

Academisch Medisch Centrum

Amsterdam, Netherlands

Leids University Medical Center (LUMC)

Leiden, Netherlands

Hospital Clinic De Barcelona

Barcelona, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06652633


Related Trials