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

A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies

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.

Study Overview

• Status: Recruiting
• Conditions: Hematological Malignancies
• Intervention / Treatment: Genetic: GLPG CAR T-cell therapy

• Study Type: Interventional
• Enrollment (Estimated): 546
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Galapagos Medical Information; Phone Number: +3215342900; Email: medicalinfo@glpg.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • Antwerp University Hospital
  • Liège, Belgium, 4032
    • Recruiting
    • Centre Hospitalier Universitaire (CHU) de Liege
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Academisch Medisch Centrum
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Amsterdam UMC
  • Leiden, Netherlands, 2333 ZA
    • Recruiting
    • Leids University Medical Center (LUMC)
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic De Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Previously treated participants with GLPG CAR T-cell therapy; All participants who have been treated with a Galapagos CAR T-cell therapy	Genetic: GLPG CAR T-cell therapy; No investigational products will be administered to participants in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Galapagos Study Director, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): July 1, 2039
• Study Completion (Estimated): July 1, 2039

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CAR T-cell therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: LTF-CL-001; 2023-510173-34-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No