GLPG CAR T-cell therapy
GeneticNo investigational products will be administered to participants in this study.
NCT Number: NCT06652633
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Antwerp University Hospital, Edegem, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No investigational products will be administered to participants in this study.
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Time frame: From infusion up to 15 years
Contact information is provided by the study sponsor or research team.
Lakefront Biotherapeutics NV
Industry
A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies
Acronym: Hesperia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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