NCT04819841

A Phase I/II Study of Nula-cel in Autologous CD34+ Hematopoietic Stem Cells to Convert HbS to HbA for Treating Severe Sickle Cell Disease

Study Summary

This study is a first-in-human, single-arm, open-label Phase I/II study of nula-cel in approximately 15 participants, diagnosed with severe Sickle Cell Disease. The primary objective is to evaluate safety of the treatment in this patient population, as well as preliminary efficacy and pharmacodynamic data.

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Interventions

nula-cel Drug ProductGENETIC
nula-cel is administered via IV infusion following a myeloablative conditioning regimen

Study Locations

FacilityCityStateCountry
Children's Hospital Los AngelesLos AngelesCaliforniaUnited States
Lucile Packard Children's HospitalPalo AltoCaliforniaUnited States
Washington UniversitySt LouisMissouriUnited States
Nationwide Children's HospitalColumbusOhioUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026