Clinical Trial

SCID-X1 Gene Therapy Via Intravenous Lentiviral (Ivlv-X1) Injection

Recruiting Phase 1/2
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Summary
This is a Phase I/II gene therapy trial treating X-linked severe combined immunodeficiency (SCID-X1) using a self-inactivating lentiviral vector (ivlv-X1) to functionally correct the genetic defect. The primary objectives are to evaluate the safety and efficacy of the direct intravenous lentiviral gene transfer protocol.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2017-07-11; most recent amendment 2026-06-18.
Status change: Enrolling by Invitation → Recruiting 2017-09-29
Status change: Not Yet Recruiting → Enrolling by Invitation 2017-07-17
Trial Details
NCT Number NCT03217617
Lead Sponsor Shenzhen Geno-Immune Medical Institute
Conditions SCID, X-Linked
Enrollment 10 participants
Start Date 2024-06-30
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-23