Hematological Malignancies
Conditions
Keywords
CAR T-cell therapy
Brief 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.
Interventions
GENETICGLPG CAR T-cell therapy
No investigational products will be administered to participants in this study.
Sponsors
Lakefront Biotherapeutics NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with targeted adverse events (AEs) | From infusion up to 15 years |
| Percentage of participants with detectable CAR transgene levels in peripheral blood | From infusion up to 15 years |
| Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy | From infusion up to 15 years |
| Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies | From infusion up to 15 years |
| Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood | From infusion up to 15 years |
| Percentage of participants who died with causes | From infusion up to 15 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with disease progression | From infusion up to 15 years |
| Time to subsequent anticancer therapy | From infusion up to 15 years |
| Overall survival | From infusion up to 15 years |
Countries
Belgium, Finland, Netherlands, Spain, United States
Contacts
CONTACTLakefront Biotherapeutics Medical Information
STUDY_DIRECTORLakefront Biotherapeutics Study Director
Lakefront Biotherapeutics NV
Outcome results
None listed