RecruitingPhase 1NCT04716452

Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase I Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (RR-AML)


Sponsor

Keystone Nano, Inc

Enrollment

15 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called C6 Ceramide NanoLiposome (CNL) in adults with acute myeloid leukemia (AML) — a type of blood cancer — that has come back after treatment or did not respond to prior treatment. **You may be eligible if:** - You are 18 or older - You have AML that has relapsed (came back) or is refractory (did not respond to prior treatment) - Your overall health and organ function (kidneys, liver, heart) are adequate - Your white blood cell count is below a certain threshold **You may NOT be eligible if:** - You have uncontrolled serious illness (heart failure, unstable heart conditions, severe psychiatric illness) - You are currently in another clinical trial or took an investigational drug within the past week - You are pregnant or breastfeeding - You had another cancer within the past 12 months (with some exceptions) - You have acute promyelocytic leukemia or AML with central nervous system involvement - You have an active HIV, hepatitis B, or hepatitis C infection - You recently had a stem cell transplant with active graft-versus-host disease Talk to your doctor to see if this trial is right for you.

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

DRUGCeramide NanoLiposome (Ceraxa)

Ceramide NanoLiposome will be given by IV twice a week. The dose, which is based on body size, will be increased for the next group of patients if the first group of patients tolerates that dose and it will decrease for the next group if they do not tolerate the dose.


Locations(1)

University of Virginia Cancer Center

Charlottesville, Virginia, United States

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NCT04716452


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