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)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06548230
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Myelogenous Leukemia (AML)
  • Myelodysplastic Syndrome(MDS)

Eligibility Criteria

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

Interventions

  • Nadunolimab — DRUG
    Give by IV
  • Azacitidine — DRUG
    Given by IV
  • Venetoclax — DRUG
    Given by mouth (PO

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ARM 1: All Patients Cycle 1
  • Experimental: ARM 1A: Cycle 2-24 for responder after Cycle 1 Mono
  • Experimental: ARM 1B: Cycle 2-24 for non responder after Cycle 1 Combo
  • Experimental: ARM 2: Relapsed/refractory AML

Primary Outcome Measure

Safety and Adverse Events [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Gautam Borthakur, MBBS
[email protected]
713-563-1586

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By research site
MD Anderson Cancer Center· Houston, TX

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