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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Lakefront Biotherapeutics NV
Study ID
NCT06652633
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GLPG CAR T-cell therapy — GENETIC
    No investigational products will be administered to participants in this study.

Study Details

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.

Key Dates

Start date
Sep 9, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2039
Completion
Jul 31, 2039

Study Design

Enrollment
546 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Previously treated participants with GLPG CAR T-cell therapy
    All participants who have been treated with a Galapagos CAR T-cell therapy

Primary Outcome Measure

Percentage of participants with targeted adverse events (AEs) [ Time Frame: From infusion up to 15 years ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Tufts Medical CenterBostonMassachusetts02111

Find similar trials in Boston, MA

By research site
Tufts Medical Center· Boston, MA

Related Studies