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

Condition(s) studied

Investigational drug(s) / intervention(s)

GLPG CAR T-cell therapy: No investigational products will be administered to participants in this study.

Study 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

Primary outcome measure(s)

• Percentage of participants with targeted adverse events (AEs) — From infusion up to 15 years
• Percentage of participants with detectable CAR transgene levels in peripheral blood — From infusion up to 15 years
• Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy — From infusion up to 15 years
• Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies — From infusion up to 15 years
• Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood — From infusion up to 15 years
• Percentage of participants who died with causes — From infusion up to 15 years

Trial sites (11)

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