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

RecruitingPhase 3

Sponsor: Lakefront Biotherapeutics NV

Conditions: Hematological Malignancies

Interventions: GLPG CAR T-cell therapy

Countries: United States, Belgium, Finland, Netherlands, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (11)

Boston, Massachusetts, United States
Edegem, Belgium
Leuven, Belgium
Liège, Belgium
Roeselare, Belgium
Woluwe-Saint-Lambert, Belgium
Helsinki, Finland
Amsterdam, Netherlands
Leiden, Netherlands
Rotterdam, Netherlands
Barcelona, Spain