Clinical trial · Interventional
Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GLPG CAR T-cell therapy | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Previously treated participants with GLPG CAR T-cell therapy
- description
- All participants who have been treated with a Galapagos CAR T-cell therapy
- interventionNames
- Genetic: GLPG CAR T-cell therapy
Primary outcomes (6)
- measure
- Percentage of participants with targeted adverse events (AEs)
- timeFrame
- From infusion up to 15 years
- measure
- Percentage of participants with detectable CAR transgene levels in peripheral blood
- timeFrame
- From infusion up to 15 years
- measure
- Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available