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)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07128381
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Chronic Myelomonocytic Leukemia (CMML)
  • Myelofibrosis (MF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axatilimab (SNDX-6352) — DRUG
    Taken orally
  • Ruxolitinib — DRUG
    Taken orally

Study Details

* 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.

Key Dates

Start date
Jan 2, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2033

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy or Combination: Treatment with Axatilimab +/- Ruxolitinib IV Q4W
    Participants will self-administered approximately 12 hours apart without regard to food

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Naveen Pemmaraju, MD
[email protected]
713-792-4956
Naveen Pemmaraju, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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