Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

Purpose

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.

Condition

  • Hematological Malignancies

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 exclusion criteria for this study

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Previously treated participants with GLPG CAR T-cell therapy 		All participants who have been treated with a Galapagos CAR T-cell therapy
  • Genetic: GLPG CAR T-cell therapy
    No investigational products will be administered to participants in this study.

Recruiting Locations

Tufts Medical Center
Boston, Massachusetts 02111

More Details

Status
Recruiting
Sponsor
Lakefront Biotherapeutics NV

Study Contact

Lakefront Biotherapeutics Medical Information
+3215342900
medicalinfo@lakefrontbio.com