CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 10 target
Drug / intervention
Direct intravenous injection of ivlv-X1 lentiviral vectorbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03217617Phase 1RecruitingOn Track
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Gene Therapy for X-linked Severe Combined Immunodeficiency (SCID-X1) Via Direct Intravenous Injection of Lentiviral Vector (Ivlv-X1)

Shenzhen Geno-Immune Medical Institute·interventional·Posted Jul 14, 2017·Updated Jun 23, 2026

In Brief

A Phase 1 clinical trial evaluating Direct intravenous injection of ivlv-X1 lentiviral vector for SCID, X-Linked. Currently recruiting, targeting 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSCID, X-Linked
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
20182019202020212022202320242025202620272028
First PostedJul 14, 2017
Enrollment StartJun 30, 2024
Primary CompletionDec 31, 2026
Study CompletionDec 31, 2027
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 9.0 years agoPrimary completion in 6 months

Arms & Interventions

Single armexperimental

In vivo LV gene transfer to treat SCID-X1

Biological: Direct intravenous injection of ivlv-X1 lentiviral vector

Interventions

Direct intravenous injection of ivlv-X1 lentiviral vectorbiological

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