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

Galapagos

Status and phase: Enrolling; Phase 3

Conditions: Hematological Malignancies

Treatments: Genetic: GLPG CAR T-cell therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06652633

LTF-CL-001

2023-510173-34-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 546 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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546 participants in 1 patient group

Previously treated participants with GLPG CAR T-cell therapy

Experimental group

Description:

All participants who have been treated with a Galapagos CAR T-cell therapy

Treatment:

Genetic: GLPG CAR T-cell therapy