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)

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.

Trial Details

NCT ID
NCT06548230
Phase
PHASE1 / PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Nadunolimab
  • Azacitidine
  • Venetoclax
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Arm 1: Diagnosis of MDS intermediate/high/very high risk by Revised International Prognostic Scoring System (IPSS-R), Untreated or up to 2 prior tr…
  • Arm 2: Diagnosis of relapsed/refractory AML (per European Leukemia Network 2022) \[26\] receiving treatment as salvage 1-2. MDS or CMML treated wit…
  • Patients aged ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2

For full eligibility, visit ClinicalTrials.gov.

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