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

Recruiting now · Phase 3

Conditions studied: Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT06652633

Run by

Lakefront Biotherapeutics NV

People needed

546

Starts

2024-09-09

Expected to finish

2039-07-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• There are no exclusion criteria for this study

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Antwerp University Hospital — Edegem, Belgium (enrolling)
• Universitair Ziekenhuis Leuven — Leuven, Belgium (enrolling)
• Centre Hospitalier Universitaire (CHU) De Liège — Liège, Belgium (enrolling)
• Algemeen Ziekenhuis Delta — Roeselare, Belgium (enrolling)
• Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium (enrolling)
• helsingin yliopistollinen sairaala comprehensive cancer center (HUS) — Helsinki, Finland (enrolling)
• Academisch Medisch Centrum (Amsterdam UMC) — Amsterdam, Netherlands (enrolling)
• Leids University Medical Center (LUMC) — Leiden, Netherlands (enrolling)
• Erasmus Medisch Centrum — Rotterdam, Netherlands (enrolling)
• Hospital Clinic De Barcelona — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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