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

Phase 3

Recruiting

• Conditions: Hematological Malignancies

• Registration Number: NCT06652633
• Lead Sponsor: Galapagos NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-09
• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Primary Completion: 2039-07
• Study Completion: 2039-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 546

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with disease progression	From infusion up to 15 years
Time to subsequent anticancer therapy	From infusion up to 15 years
Overall survival	From infusion up to 15 years

Trial Locations

Locations (6)

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