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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Keystone Nano, Inc
Study ID
NCT04716452
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ceramide NanoLiposome (Ceraxa) — DRUG
    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.

Study Details

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

Key Dates

Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Administration of Ceramide NanoLiposome
    Ceramide NanoLiposome will be administered by Intravenous Dosing twice per week in accordance with the protocol relative to dose escalation. There is no placebo group or arm of the study.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Cancer CenterCharlottesvilleVirginia22903
Cory Caldwell
[email protected]
434-297-4182
Michael Keng, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Virginia Cancer Center· Charlottesville, VA

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