CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 10 target
Drug / intervention
Direct intravenous injection of ivlv-ADA lentiviral vectorgenetic
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.

Search/NCT03645460
NCT03645460N/ARecruitingOn Track

Gene Therapy Via Intravenous Injection of Lentiviral Vector (Ivlv-ADA) for the Treatment of Adenosine Deaminase-severe Combined Immunodeficiency (ADA-SCID)

Shenzhen Geno-Immune Medical Institute·interventional·Posted Aug 24, 2018·Updated Jun 23, 2026

In Brief

A clinical study evaluating Direct intravenous injection of ivlv-ADA lentiviral vector for Adenosine DeAminase Severe Combined ImmunoDeficiency (ADA-SCID). Currently recruiting, targeting 10 participants across 1 site.

Detailed Summary

This is a Phase I/II trial of in vivo lentiviral gene therapy for treating adenosine deaminase severe combined immunodeficiency (ADA-SCID) using a self-inactivating lentiviral vector (LV) ivlv-ADA to functionally correct the genetic defect. The primary objectives are to evaluate the safety and efficacy of the direct intravenous (iv) LV gene therapy protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ARecruiting
2019202020212022202320242025202620272028
First PostedAug 24, 2018
Enrollment StartJun 30, 2024
Primary CompletionDec 31, 2026
Study CompletionDec 31, 2027
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 7.9 years agoPrimary completion in 6 months

Arms & Interventions

Direct intravenous injection of ivlv-ADA lentiviral vectorexperimental

Direct intravenous injection of ivlv-ADA lentiviral vector

Genetic: Direct intravenous injection of ivlv-ADA lentiviral vector

Interventions

Direct intravenous injection of ivlv-ADA lentiviral vectorgenetic

Injection of ivlv-ADA lentiviral vector at \~1x10\^9 per kg body weight