RecruitingPhase 1

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

United States15 participantsStarted 2025-10-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent is obtained prior to conducting any study-specific screening procedures.
. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.
. Age and Disease: ≥ 18 years of age with refractory or relapsed AML
. Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
. ECOG performance status must be ≤2
. Peripheral white blood cell (WBC) count \<30,000/µL. For cyto-reduction, the following are allowed to reduce WBC count to \< 30,000/µL:
. Adequate organ function as evidenced by the following laboratory findings:

Exclusion criteria

. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months before registration, or psychiatric illness/social situations that would limit compliance with study requirements.
. Patients may not be receiving any other concurrent investigational agents during study treatment and not for at least within one week prior to starting study treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients with Dose Limiting Toxicities as defined in Protocol Section 13.5

Timeframe: At the end of the the first cycle of administration (each cycle is 28 days)

Number of Patients with Adverse Events

Timeframe: Through study completion, an average of 24 weeks

Severity of Adverse Events

Timeframe: Through study completion, an average of 24 weeks

Duration of Adverse Events

Timeframe: Length of Adverse Events as measured in days, measured through study completion, an average of 24 weeks

Duration of therapy

Timeframe: Through study completion, an average of 24 weeks

Dose Levels achieved during study

Timeframe: Through study completion, an average of 24 weeks

Concentration Max (C Max)

Timeframe: Through cycle one, 28 days (each cycle is 28 days)

Trial details

NCT IDNCT04716452

SponsorKeystone Nano, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

James H Adair, Ph.D.

814-360-4654 jadair@pendreabio.com

View on ClinicalTrials.gov More Acute Myeloid Leukemia, in Relapse trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent is obtained prior to conducting any study-specific screening procedures.
. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.
. Age and Disease: ≥ 18 years of age with refractory or relapsed AML
. Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
. ECOG performance status must be ≤2
. Peripheral white blood cell (WBC) count \<30,000/µL. For cyto-reduction, the following are allowed to reduce WBC count to \< 30,000/µL:
. Adequate organ function as evidenced by the following laboratory findings:

Exclusion criteria

. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months before registration, or psychiatric illness/social situations that would limit compliance with study requirements.
. Patients may not be receiving any other concurrent investigational agents during study treatment and not for at least within one week prior to starting study treatment.

What they're measuring

Number of Patients with Dose Limiting Toxicities as defined in Protocol Section 13.5

Timeframe: At the end of the the first cycle of administration (each cycle is 28 days)

Number of Patients with Adverse Events

Timeframe: Through study completion, an average of 24 weeks

Severity of Adverse Events

Timeframe: Through study completion, an average of 24 weeks

Duration of Adverse Events

Timeframe: Length of Adverse Events as measured in days, measured through study completion, an average of 24 weeks

Duration of therapy

Timeframe: Through study completion, an average of 24 weeks

Dose Levels achieved during study

Timeframe: Through study completion, an average of 24 weeks

Concentration Max (C Max)

Timeframe: Through cycle one, 28 days (each cycle is 28 days)