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

NCT06652633 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2026-02-05

No results posted yet for this 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.

Conditions

Interventions

GENETIC

GLPG CAR T-cell therapy

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

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Galapagos Study Director · Galapagos NV

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2039-07-31
Completion
2039-07-31

Countries

  • Belgium
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652633 on ClinicalTrials.gov