Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
NCT ID: NCT06652633
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
546 participants
INTERVENTIONAL
2024-09-09
2039-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Previously treated participants with GLPG CAR T-cell therapy
All participants who have been treated with a Galapagos CAR T-cell therapy
GLPG CAR T-cell therapy
No investigational products will be administered to participants in this study.
Interventions
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GLPG CAR T-cell therapy
No investigational products will be administered to participants in this study.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2023-510173-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
LTF-CL-001
Identifier Type: -
Identifier Source: org_study_id
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