RecruitingNot ApplicableNCT04797260

Phase I/II Clinical Trial Stem Cell Gene Therapy in RAG1-Deficient SCID

Phase I/II Clinical Trial of Autologous Hematopoietic Stem Cell Gene Therapy in RAG1-Deficient Severe Combined Immunodeficiency


Sponsor

Leiden University Medical Center

Enrollment

10 participants

Start Date

Jul 23, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, non-randomized, open-label, two-centre phase I/II intervention study designed to treat children up to 24 months of age with RAG1-deficient SCID with an indication for allogeneic hematopoietic stem cell transplantation but lacking an HLA-matched donor. The study involves infusion of autologous CD34+ cells transduced with the pCCL.MND.coRAG1.wpre lentiviral vector (hereafter called RAG1 LV CD34+ cells) in five patients with RAG1-deficient SCID.


Eligibility

Min Age: 8 WeeksMax Age: 24 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Gene therapy for people with severe combined immunodeficiency due to rag1 deficiency. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 8 Weeks to 24 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICGene therapy

Patients will be infused with autologous CD34+ cells transduced with the pCCL.MND.coRAG1.wpre lentiviral vector (RAG1 LV CD34+ cells).


Locations(7)

The Royal Childrens Hospital

Melbourne, Australia

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Leiden University Medical Center

Leiden, Netherlands

Wroclaw Medical University

Wroclaw, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Erciyes Üniversitesi TIP Fakültesi

Kayseri, Turkey (Türkiye)

University College London Great Ormond Street

London, United Kingdom

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NCT04797260