RecruitingPhase 1Phase 2NCT05071222

Safety and Efficacy Study of Transplantation of Autologous CD34+ Cells Transduced With the G2ARTE Lentiviral Vector Expressing the DCLRE1C cDNA in Artemis (DCLRE1C) Deficient Severe Combined Immunodeficiency Patients (ARTEGENE)

A Phase 1/2 Open Label Non Randomized Study, Multicentric, Single Arm Evaluating the Safety and Efficacy of Gene Therapy of the Severe Combined Immunodeficiency (SCID) Caused by Mutations in the Human DCLRE1C Gene (Artemis) by Transplantation of a Single Dose of Autologous CD34+ Cells Transduced ex Vivo With the G2ARTE Lentiviral Vector Expressing the DCLRE1C cDNA


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

7 participants

Start Date

Jul 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the Safety and Efficacy of Gene Therapy of the severe combined immunodeficiency (SCID) caused by mutations in the human DCLRE1C gene (Artemis) by transplantation of a single dose of autologous CD34+ cells transduced ex vivo with the G2ARTE lentiviral vector expressing the DCLRE1C cDNA.


Eligibility

Max Age: 47 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ARTEGENE drug product for people with artemis (dclre1c ) deficient severe combined immunodeficiency. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 47 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

GENETICARTEGENE drug product

Each patient will receive a single intravenous infusion of ARTEGENE drug product at D0.


Locations(1)

Department of Pediatric Immunology, Hematology and Rheumatology UIHR, Necker-Enfants Malades Hospital

Paris, France

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NCT05071222