Clinical trial NCT06652633: Long-term Follow-up of Participants Treated with Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
Official title: A Long-term Follow-up Study for Patients Treated with Galapagos CAR T-cell Therapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hematological Malignancies
Keywords: CAR T-cell therapy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
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
timeFrame: From infusion up to 15 years
measure: Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies
timeFrame: From infusion up to 15 years
measure: Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood
timeFrame: From infusion up to 15 years
measure: Percentage of participants who died with causes
timeFrame: From infusion up to 15 years
Secondary outcomes:
measure: Percentage of participants with disease progression
timeFrame: From infusion up to 15 years
measure: Time to subsequent anticancer therapy
timeFrame: From infusion up to 15 years
measure: Overall survival
timeFrame: From infusion up to 15 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) De Liège
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Leiden
country: Netherlands
facility: Leids University Medical Center (LUMC)
city: Barcelona
country: Spain
facility: Hospital Clinic De Barcelona
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References: