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NCT03961243 · ClinicalTrials.gov record · last posted 2026-08-26

Lentiviral FIX Gene Therapy

StatusNot Yet Recruiting
PhasePhase 1
Started2027-06-01
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from the ClinicalTrials.gov record
This study is a Phase I trial using an advanced lentiviral vector to deliver a functional gene for human clotting factor IX into patients with hemophilia B, to evaluate the safety and efficacy of infusion of lentiviral gene modified autologous stem cells in patients.

Protocol amendment history 3 changes detected by DataLookout

2026-08-27
Trial status changed: Recruiting → Not Yet Recruiting
2026-08-27
Primary completion pushed: 2027-05-31 → 2028-05-31
2026-08-27
Completion pushed: 2028-06-01 → 2028-12-31
Trial Details
NCT Number NCT03961243
Lead Sponsor Shenzhen Geno-Immune Medical Institute
Conditions Hemophilia B
Enrollment 10 participants
Start Date 2027-06-01
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-26