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NCT06652633 · ClinicalTrials.gov registry record · Phase 3
Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
A Phase 3 study, sponsored by Lakefront Biotherapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 546
- Enrollment target
NCT06652633: Recruiting Phase 3 study, sponsored by Lakefront Biotherapeutics.
NCT06652633 is a Phase 3 study that is actively recruiting participants, run by Lakefront Biotherapeutics. The registered enrollment target is 546 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06652633, a Phase 3 study, is actively recruiting participants, sponsored by Lakefront Biotherapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 546 participants
- Enrollment target
Study 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.
Interventions
- GENETIC GLPG CAR T-cell therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2024-09-09 |
| Est. Completion | 2039-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06652633
The ClinicalTrials.gov registry entry for NCT06652633 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lakefront Biotherapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GLPG CAR T-cell therapy is the first listed.
NCT06652633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06652633 about?
NCT06652633 is a clinical study titled "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 integratin...
What is the current status of trial NCT06652633?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 546 participants. The study started on 2024-09-09. Estimated completion is 2039-07.
What interventions are being tested in trial NCT06652633?
The interventions under investigation include: GLPG CAR T-cell therapy (GENETIC).
Who is sponsoring clinical trial NCT06652633?
This trial is sponsored by Lakefront Biotherapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
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