OncoMatch/Clinical Trials/NCT06548230
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)
Is NCT06548230 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Nadunolimab and Azacitidine for myelodysplastic syndrome(mds).
Treatment: Nadunolimab · Azacitidine · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent — for MDS or CMML progressing to AML
MDS or CMML treated with hypomethylating agent (HMA) therapies who progress to AML
Cannot have received: organ transplantation
Exception: allogenic stem-cell transplantation allowed if >3 months prior and no active GVHD >Grade 1 or requiring transplant-related immunosuppression (except low dose cyclosporine and tacrolimus)
Prior organ transplantation including allogenic stem-cell transplantation within 3 months prior to planned enrollment, active graft versus host disease (GVHD) >Grade 1 or requiring transplant-related immunosuppression with the exception of low dose cyclosporine and tacrolimus
Lab requirements
Blood counts
White blood cell count <10 x 10^9/L (hydroxyurea may be used to reduce WBC count)
Kidney function
Creatinine clearance (CrCl) ≥ 40 mL/min (Cockcroft-Gault, MDRD eGFR, or 24h urine); for BMI >23, adjusted body weight recommended
Liver function
Direct bilirubin <1.5 x ULN unless considered due to Gilbert's syndrome; AST or ALT ≤2.0 x ULN (≤3.0 x ULN if deemed related to leukemia)
Serum biochemical values with the following limits: adequate renal function as demonstrated by a creatinine clearance (CrCl) ≥ 40 mL/min... Direct bilirubin <1.5 x ULN unless considered due to Gilbert's syndrome; AST or ALT ≤2.0 x ULN (≤3.0 x ULN if deemed related to leukemia); White blood cell count <10 x 10^9/L. Hydroxyurea may be used to reduce the WBC count to < 10x10^9/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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