Back to Trials
NCT06652633PHASE3Recruiting

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

Lakefront Biotherapeutics NV

Start Date

9/9/2024

Completion Date

7/1/2039

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

GENETIC

GLPG CAR T-cell therapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Hematological Malignancies

Locations

Tufts Medical Center

Boston, Massachusetts 02111

United States

Antwerp University Hospital

Edegem, 2650

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Centre Hospitalier Universitaire (CHU) De Liège

Liège, 4032

Belgium

Algemeen Ziekenhuis Delta

Roeselare, 8800

Belgium

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200

Belgium

helsingin yliopistollinen sairaala comprehensive cancer center (HUS)

Helsinki, 00290

Finland

Academisch Medisch Centrum (Amsterdam UMC)

Amsterdam, 1105 AZ

Netherlands

Leids University Medical Center (LUMC)

Leiden, 2333 ZA

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015

Netherlands

Hospital Clinic De Barcelona

Barcelona, 08036

Spain