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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06548230 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior organ transplantation disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify