Recruiting
Phase 3

GLPG CAR T-cell

Sponsor:

Lakefront Biotherapeutics NV

Code:

NCT06652633

Conditions

Hematological Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLPG CAR T-cell therapy

Study Details

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.

Conditions

Hematological Malignancies

Study ID

NCT06652633

Start date

Sep 9, 2024

Status verified date

Jul, 2026

Completion date

Jul, 2039

Anticipated

Primary completion date

Jul, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

546 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Previously treated participants with GLPG CAR T-cell therapy

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

Interventions

GLPG CAR T-cell therapy

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

Primary outcome measure

  • Percentage of participants with targeted adverse events (AEs) [ Time Frame: From infusion up to 15 years ]
  • Percentage of participants with detectable CAR transgene levels in peripheral blood [ Time Frame: From infusion up to 15 years ]
  • Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy [ Time Frame: From infusion up to 15 years ]
  • 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 ]
  • Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood [ Time Frame: From infusion up to 15 years ]
  • Percentage of participants who died with causes [ Time Frame: From infusion up to 15 years ]

Central Contacts and Locations

Central contacts

Lakefront Biotherapeutics Medical Information

+3215342900medicalinfo@lakefrontbio.com

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

More Information

Sponsor

Lakefront Biotherapeutics NV

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • CAR T-cell therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lakefront Biotherapeutics NV on 2026-07-13.