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

Last updated: October 21, 2024
Sponsor: Galapagos NV
Overall Status: Active - Recruiting

Phase

3

Condition

Hematologic Neoplasms

Hematological Disorders

Treatment

GLPG CAR T-cell therapy

Clinical Study ID

NCT06652633
LTF-CL-001
2023-510173-34-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • All participants who have been treated with a Galapagos CAR T-cell therapy in aclinical trial or Managed Access Program.

Exclusion

Exclusion Criteria:

  • There are no exclusion criteria for this study

Study Design

Total Participants: 546
Treatment Group(s): 1
Primary Treatment: GLPG CAR T-cell therapy
Phase: 3
Study Start date:
September 09, 2024
Estimated Completion Date:
July 31, 2039

Connect with a study center

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) De Liège

    Liège, 4032
    Belgium

    Active - Recruiting

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Leids University Medical Center (LUMC)

    Leiden, 2333 ZA
    Netherlands

    Active - Recruiting

  • Hospital Clinic De Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

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