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C6 Ceramide NanoLiposome (Ceraxa) for Relapsed/Refractory AML

This study is testing a new treatment called Ceramide NanoLiposome (Ceraxa) for people with acute myeloid leukemia (AML) that has come back (relapsed) or didn't respond to previous treatments (refractory). Researchers have seen in lab tests that Ceraxa can fight AML cells. The main goal of this study is to find out how safe Ceraxa is when given by itself, and to determine the right dose for future studies where it might be combined with other cancer drugs. You would receive Ceraxa through an IV twice a week. This study is for adults aged 18 or older with relapsed or refractory AML. Success in this study means understanding the safety of Ceraxa and finding a safe dose. The study is currently unclear on its recruitment status and plans to enroll 15 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to evaluate the safety of Ceramide NanoLiposome (Ceraxa) in a small group of patients.
What's involved
You would receive Ceramide NanoLiposome (Ceraxa) through an IV twice a week. Blood samples will be collected regularly to see how your body responds.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored through study completion, which is an average of 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04716452

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Keystone Nano, Inc
~15 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Ceramide NanoLiposome (Ceraxa)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with Dose Limiting Toxicities as defined in Protocol Section 13.5
Measured over At the end of the the first cycle of administration (each cycle is 28 days)
+13 more outcomes measured

Conditions

Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia, Refractory
Refractory/Relapse Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Daniel Vlock, MD · STUDY_DIRECTOR · Keystone Nano, Inc
  • Christopher Prior, Ph.D. · STUDY_CHAIR · Keystone Nano

Who to contact

James H Adair, Ph.D.
[email protected]
814-360-4654
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

hydroxyurea is allowed during screening and through the end of Cycle,
cytarabine is allowed during screening but not after registration and should be limited 1 g/m2 or less from time of consent to registration. 7. Adequate organ function as evidenced by the following laboratory findings:
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or \< 3 x ULN for patients with Gilbert-Meulengracht Syndrome
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN if not attributed to leukemia, or ≤ 5 x ULN if attributed to leukemia
Creatinine clearance \> 60 mL/min.

What this trial measures

  • Number of Patients with Dose Limiting Toxicities as defined in Protocol Section 13.5At the end of the the first cycle of administration (each cycle is 28 days)

    Dose Limiting Toxicities within the first cycle of CNL monotherapy. See section 13.5 of Protocol for the complete list of Dose Limiting Toxicities

  • Number of Patients with Adverse EventsThrough study completion, an average of 24 weeks

    Number of Patients with Adverse Events

  • Severity of Adverse EventsThrough study completion, an average of 24 weeks

    Severity of Adverse Event As Described in Protocol

  • Duration of Adverse EventsLength of Adverse Events as measured in days, measured through study completion, an average of 24 weeks

    Duration of Adverse Events, As Described in Protocol, measured in days

  • Duration of therapyThrough study completion, an average of 24 weeks

    Duration of therapy provided as measured in days

  • Dose Levels achieved during studyThrough study completion, an average of 24 weeks

    Dose levels administered in milligrams per m2

  • Concentration Max (C Max)Through cycle one, 28 days (each cycle is 28 days)

    Maximum Serum Concentration measured, in nanograms/milliliter

  • Time to Maximum Study Drug (T Max)Through cycle one, 28 days (each cycle is 28 days)

    Time to maximum concentration measured, in minutes

  • Half Life of Study DrugThrough cycle one, 28 days (each cycle is 28 days)

    Time for drug to be reduced to half of the starting concentration (in minutes)

  • Study Drug ClearanceThrough cycle one, 28 days (each cycle is 28 days)

    The Amount of Study Drug Cleared per unit time (Nanograms/Minute)

  • Ratio of C16/C24 CeramidesAfter one cycle of therapy (Day 28)

    Ratio of Ceramide 16 to Ceramide 24 (ng of C16/ng of C18) from bone marrow biopsy

  • Clinical Response - Complete ResponseAfter Cycle Two (56 days)

    Complete Response

  • Clinical Response - Complete Response with Incomplete Hematologic Recovery (CRi)After Cycle Two (56 days)

    Complete Response with Incomplete Hematological Recovery as defined by blasts in bone marrow

  • Clinical Response - Partial RemissionAfter Cycle Two (56 days)

    Partial Remission (as defined by blasts in bone marrow)