OncoMatch/Clinical Trials/NCT07128381
Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)
Is NCT07128381 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Axatilimab (SNDX-6352) and Ruxolitinib for myelofibrosis (mf).
Treatment: Axatilimab (SNDX-6352) · Ruxolitinib — * To find the recommended dose of axatilimab given alone and in combination with ruxolitinib in patients with MF and CMML. * To learn if axatilimab given in combination with ruxolitinib can help to control MF and CMML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: JAK inhibitor — MF, phase 1 dose escalation (Cohort A and B): at least 1 prior therapy for MF or with suboptimal response after at least 3 months of therapy with a JAK inhibitor
at least 1 prior therapy for MF or with suboptimal response after at least 3 months of therapy with a JAK inhibitor
Must have received: MF therapy — MF, phase 2 relapsed cohort (Cohort C): at least 1 prior MF therapy
Relapsed cohort (Cohort C): Patients with at least 1 prior MF therapy
Must have received: hydroxyurea — CMML, proliferative: refractory to hydroxyurea (for patients with proliferative CMML defined as WBC>13x10^9/L)
Diagnosis of CMML refractory to treatment with hydroxyurea (for patients with proliferative CMML defined as WBC.13x109/L)
Must have received: hypomethylating agent — CMML: at least 4 cycles of treatment with hypomethylating agent, with relapse/progression after any number of cycles of hypomethylating agent therapy or who are intolerant of treatment with either therapy
at least 4 cycles of treatment with hypomethylating agent, with relapse/progression after any number of cycles of hypomethylating agent therapy or who are intolerant of treatment with either therapy
Cannot have received: CSF1R inhibitor
prior CSF1-R inhibitor therapy
Lab requirements
Blood counts
Platelet count <50x10^9/L prior to enrollment and treatment initiation (for ruxolitinib combination cohorts only) except if related to either treatment for MF or CMML or treatment with cytotoxic therapy for any other reason
Kidney function
Serum creatinine clearance >30mL/min and no end/stage renal disease (using Cockcroft-Gault)
Liver function
total bilirubin ≤3 x ULN, AST or ALT ≤3xULN unless related to disease involvement
Cardiac function
NYHA class 2B or better; NYHA Class III or IV congestive heart failure or LVEF <50% by echocardiogram or MUGA scan excluded; history of myocardial infarction or thromboembolic disease within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias excluded
Adequate hepatic function with total bilirubin ≤3 x ULN, AST or ALT ≤3xULN unless related to disease involvement. Serum creatinine clearance >30mL/min and no end/stage renal disease (using Cockcroft-Gault). Platelet count <50x10^9/L prior to enrollment and treatment initiation (for ruxolitinib combination cohorts only) except if related to either treatment for MF or CMML or treatment with cytotoxic therapy for any other reason. NYHA class 2B or better; NYHA Class III or IV congestive heart failure or LVEF <50% by echocardiogram or MUGA scan excluded; history of myocardial infarction or thromboembolic disease within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
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