RecruitingPhase 1Phase 2NCT06548230

A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called NADUNOLIMAB in combination with azacitidine (with or without venetoclax) for people with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) — two serious blood cancers. The goal is to find out if adding NADUNOLIMAB improves treatment responses in patients who either haven't yet tried standard options or haven't responded well to them. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with intermediate, high, or very high risk MDS and have had no more than 2 prior treatments (Arm 1), OR - You have relapsed or refractory AML and are starting your 1st or 2nd salvage treatment, or your MDS progressed to AML (Arm 2) - You are in reasonable physical health (ECOG score 2 or less) - Your organ function is adequate **You may NOT be eligible if...** - You have active uncontrolled infections - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active brain involvement from your cancer - You have received certain prior treatments that disqualify you 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

DRUGNadunolimab

Give by IV

DRUGAzacitidine

Given by IV

DRUGVenetoclax

Given by mouth (PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06548230


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