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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
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
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.
What is being tested
- GLPG CAR T-cell therapy (genetic)
Sponsor: Lakefront Biotherapeutics NV · Participants: 546 · Started: Sep 9, 2024
Contact the study team
- Lakefront Biotherapeutics Medical Information · Phone: +3215342900
Official record on ClinicalTrials.gov — NCT06652633
Locations in the U.S.
| Massachusetts | Tufts Medical Center, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.