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

NCT ID: NCT06652633

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2039-07-31

Brief Summary

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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

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Conditions

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Hematological Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Previously treated participants with GLPG CAR T-cell therapy

All participants who have been treated with a Galapagos CAR T-cell therapy

Group Type EXPERIMENTAL

GLPG CAR T-cell therapy

Intervention Type GENETIC

No investigational products will be administered to participants in this study.

Interventions

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GLPG CAR T-cell therapy

No investigational products will be administered to participants in this study.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galapagos Study Director

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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Antwerp University Hospital

Edegem, , Belgium

Site Status RECRUITING

Centre Hospitalier Universitaire (CHU) De Liège

Liège, , Belgium

Site Status RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status RECRUITING

Leids University Medical Center (LUMC)

Leiden, , Netherlands

Site Status RECRUITING

Hospital Clinic De Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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Belgium Netherlands Spain

Central Contacts

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Galapagos Medical Information

Role: CONTACT

+3215342900

Other Identifiers

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2023-510173-34-00

Identifier Type: CTIS

Identifier Source: secondary_id

LTF-CL-001

Identifier Type: -

Identifier Source: org_study_id

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