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

NCT06652633 | Recruiting Phase 3 DMC

• 2 other identifiers: LTF-CL-0012023-510173-34-00
• Study Type: interventional
• Target: 546
• Locations: 3 countries
• Sites: 6

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

Keywords

CAR T-cell therapy

Outcome Measures

Primary Outcomes (6)

• Percentage of participants with targeted adverse events (AEs)

  From infusion up to 15 years

• Percentage of participants with detectable CAR transgene levels in peripheral blood

  From infusion up to 15 years

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

  From infusion up to 15 years

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

  From infusion up to 15 years

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

  From infusion up to 15 years

• Percentage of participants who died with causes

  From infusion up to 15 years

Secondary Outcomes (3)

• Percentage of participants with disease progression

  From infusion up to 15 years

• Time to subsequent anticancer therapy

  From infusion up to 15 years

• Overall survival

  From infusion up to 15 years

Study Arms (1)

Previously treated participants with GLPG CAR T-cell therapy

EXPERIMENTAL

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

Genetic: GLPG CAR T-cell therapy

Interventions

GLPG CAR T-cell therapy GENETIC

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

Previously treated participants with GLPG CAR T-cell therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (6)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

Centre Hospitalier Universitaire (CHU) De Liège

Liège, 4032, Belgium

RECRUITING

Amsterdam UMC

Amsterdam, 1081 HV, Netherlands

RECRUITING

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Leids University Medical Center (LUMC)

Leiden, 2333 ZA, Netherlands

RECRUITING

Hospital Clinic De Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Central Study Contacts

Galapagos Medical Information

CONTACT

+3215342900; medicalinfo@glpg.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): July 1, 2039
• Study Completion (Estimated): July 1, 2039
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); ES (1); NL (3)