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NCT Number: NCT06652633

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Antwerp University Hospital, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLPG CAR T-cell therapy

Genetic

No investigational products will be administered to participants in this study.

Primary outcomes

  1. Percentage of participants with targeted adverse events (AEs)

    Time frame: From infusion up to 15 years

  2. Percentage of participants with detectable CAR transgene levels in peripheral blood

    Time frame: From infusion up to 15 years

  3. Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy

    Time frame: From infusion up to 15 years

  4. Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies

    Time frame: From infusion up to 15 years

  5. Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood

    Time frame: From infusion up to 15 years

  6. Percentage of participants who died with causes

    Time frame: From infusion up to 15 years

Secondary outcomes

  1. Percentage of participants with disease progression

    Time frame: From infusion up to 15 years

  2. Time to subsequent anticancer therapy

    Time frame: From infusion up to 15 years

  3. Overall survival

    Time frame: From infusion up to 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Lakefront Biotherapeutics Medical Information

CONTACT

[email protected]

+3215342900

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies

Acronym: Hesperia

Important dates

Study start
2024
Primary completion
2039
Study completion
2039
First posted
Oct 22, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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