Long-term follow-up for patients treated with Galapagos CAR T-cell therapies
A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies
This study is checking how well Galapagos CAR T-cell therapies work and their safety for patients over 15 years after treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 546 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Galapagos NV Industry-sponsored |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 6 sites (Edegem and 5 other locations) |
| Trial ID | NCT06652633 on ClinicalTrials.gov |
What this trial studies
This study involves a long-term follow-up of participants who have received Galapagos CAR T-cell therapies to evaluate their safety and efficacy over a period of 15 years post-infusion. The study aims to monitor participants for delayed adverse events and assess the long-term benefit/risk profile of the treatment. It also includes monitoring for replication-competent lentivirus and the persistence of CAR-T cells in the patients' systems. This follow-up is in accordance with health authorities' guidelines for gene therapy products.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have previously been treated with Galapagos CAR T-cell therapies in clinical trials or managed access programs.
Not a fit: Patients who have not received Galapagos CAR T-cell therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of CAR T-cell therapies for patients with hematological malignancies.
How similar studies have performed: Other studies have shown the importance of long-term follow-up in CAR T-cell therapies, indicating that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edegem and 5 other locations
- Antwerp University Hospital — Edegem, Belgium (Recruiting)
- Centre Hospitalier Universitaire (CHU) De Liège — Liège, Belgium (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Academisch Medisch Centrum — Amsterdam, Netherlands (Recruiting)
- Leids University Medical Center (LUMC) — Leiden, Netherlands (Recruiting)
- Hospital Clinic De Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Galapagos Medical Information
- Email: medicalinfo@glpg.com
- Phone: +3215342900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.