RecruitingPhase 1Phase 2NCT04819841

Gene Correction in Autologous CD34+ Hematopoietic Stem Cells (HbS to HbA) to Treat Severe Sickle Cell Disease

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


Sponsor

Kamau Therapeutics

Enrollment

15 participants

Start Date

Nov 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying nula-cel Drug Product for people with sickle cell disease. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 12 Years to 40 Years.

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

GENETICnula-cel Drug Product

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


Locations(4)

Children's Hospital Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

Washington University

St Louis, Missouri, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT04819841


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