MedTrace Logo

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

NCT03217617 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-23

No results posted yet for this study

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.

Conditions

  • SCID, X-Linked

Interventions

BIOLOGICAL

Direct intravenous injection of ivlv-X1 lentiviral vector

ivlv-X1 LV intravenous injection at a dose of \~1x10e9/kg body weight.

Sponsors & Collaborators

  • Shenzhen Geno-Immune Medical Institute

    lead OTHER

Principal Investigators

  • Lung-Ji Chang, Ph.D · Shenzhen Geno-Immune Medical Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217617 on ClinicalTrials.gov