M.D. Anderson Cancer Center
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.
Primary Objectives: To determine the safety and recommended phase 2 dose (RP2D) of nadunolimab in combination with azacitidine in intermediate/high/very high risk MDS (International prognostic scoring system revised/IPSS-R) who are untreated or had up to 2 prior treatments (Arm 1) or in combination with azacitidine and venetoclax in patients with relapsed/refractory AML receiving treatment as first or second salvage (Arm 2). Secondary Objectives: To assess the complete remission (CR)+ CR with incomplete count recovery (CRi) + partial remission (PR)+ morphologic leukemia free state (MLFS) ra…
Inclusion Criteria: 1. Diagnosis * Arm 1: Diagnosis of MDS intermediate/high/very high risk by Revised International Prognostic Scoring System (IPSS-R), Untreated or up to 2 prior treatments. * Arm 2: Diagnosis of relapsed/refractory AML (per European Leukemia Network 2022) \[26\] receiving treatment as salvage 1-2. MDS or CMML treated with hypomethylating agent (HMA) therapies who progress to AML and have no available better therapies or are not candidates for available therapies, will be eligible at the time of progression to AML. 2. Patients aged ≥18 years 3. Eastern Cooperative Onc…
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