Status:
ENROLLING_BY_INVITATION
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Keystone Nano, Inc
Collaborating Sponsors:
University of Virginia
Milton S. Hershey Medical Center
Conditions:
Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia, Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
Detailed Description
The research team has shown that C6 ceramide nanoliposome (CNL) has anti-cancer activity in laboratory models of AML and that when it is combined with other cancer-fighting drugs, it works better. Th...
Eligibility Criteria
Inclusion
- 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
- Refractory AML: Patients who fail to achieve a complete remission (CR) after one line of AML directed therapy
- Relapsed AML: Patients who achieved a complete remission (CR) with one or more prior lines of AML directed therapy but then developed a relapse of AML.
- Note: Patients are eligible even if they have not received intensive induction chemotherapy but have been treated with other AML directed therapy like hypomethylating agents (azacitidine, decitabine).
- Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2
- Peripheral white blood cell (WBC) count \<30,000/µL. For cyto-reduction, hydroxyurea is allowed during screening and through Cycle 2, Day 3 to reduce WBC count to \< 30,000 µL.
- 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) ≤ 2.5 × ULN
- Creatinine clearance \> 60 mL/min
- QT-interval corrected according to Fridericia's formula (QTcF) \< 450 ms on one electrocardiogram (ECG) at screening
Exclusion
- Patients meeting any of the following criteria are ineligible for study entry:
- 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, or have received any investigational agent within one week of registration.
- Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.
- History of any other malignancies within the preceding 12 months before registration with the exception of in-situ cancer, non-muscle invasive bladder cancer, prostate, basal or squamous cell skin cancer
- Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk
- Evidence of isolated extramedullary disease
- Acute Promyelocytic Leukemia or AML with active central nervous system (CNS) involvement
- Untreated severe (in the opinion of the treating investigator) infection
- Active and uncontrolled infection with HIV (viral load is detectable by PCR)
- Active infection with Hepatitis B virus (HbSAg positive or PCR with detectable viral load) or Hepatitis C virus (viral load detectable by PCR).
- Past Hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low dose prednisone (5 mg), or calcineurin inhibitors within the 4 weeks before registration
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04716452
Start Date
October 1 2025
End Date
October 1 2027
Last Update
December 5 2025
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22903