RecruitingPhase 1NCT05241444

CD4^LVFOXP3 in Participants With IPEX

Phase 1 Study of Autologous CD4^LVFOXP3 in Participants With Immune Dysregulation Polyendocrinopathy Enteropathy X-linked (IPEX) Syndrome


Sponsor

Bacchetta, Rosa, MD

Enrollment

30 participants

Start Date

Mar 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This first-in-human, Phase 1 clinical trial will test the feasibility of the manufacturing and the safety of the administration of CD4\^LVFOXP3 in up to 30 evaluable human participants with IPEX and evaluate the impact of the CD4\^LVFOXP3 infusion on the disease.


Eligibility

Sex: MALEMin Age: 4 MonthsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CD4 for people with ipex. The study is currently recruiting participants at 1 location. People eligible for this study include aged This first-in-human, Phase 1 clinical trial will test the feasibility of the manufacturing and the safety of the administration of CD4\ to LVFOXP3 in up to 30 evaluable human participants with IPEX and evaluate the impact of the CD4\.

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

BIOLOGICALCD4^LVFOXP3

Infusion of autologous CD4+ T cells that have undergone lentiviral-mediated gene transfer of: i) healthy human FOXP3 gene leading to persistent high FOXP3 expression and acquisition of Treg-like cell function; and ii) human CD271 surface marker gene that allows tracking and quantification of the CD4\^LVFOXP3 in the blood.


Locations(1)

Lucile Packard Children's Hospital

Palo Alto, California, United States

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NCT05241444


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