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Clinical Trial Report
Gene Therapy Trial Report
Summary
SCID-X1 Gene Therapy Via Intravenous Lentiviral (Ivlv-X1) Injection
NCTID
NCT03217617
(View at clinicaltrials.gov)
Description
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.
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Development Status
Active
Indication
X-linked Severe Combined Immunodeficiency (XSCID)
Disease Ontology Term
DOID:0060013
Compound Name
Ivlv-X1 lentiviral vector
Sponsor
Shenzhen Geno-Immune Medical Institute
Funder Type
Other
Recruitment Status
Recruiting
Enrollment Count
10
Results Posted
Not Available
Therapy Information
Target Gene/Variant
IL2RG
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Functional gene replacement
Route of Administration
Intravenous
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
LV
Editor Type
Dose 1
1E9 vg/kg
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2017-07-03
Completion Date
2027-12-31
Last Update
2024-07-08
Participation Criteria
Eligible Age
1 Month - 1 Year
Standard Ages
Child
Sexes Eligible for Study
MALE
Locations
No.of Trial Sites
2
Locations
China
Regulatory Information
Has US IND
False
FDA Designations
Recent Updates
Resources/Links
Resources/Links
No External Links Available.