A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Relapsed/Refractory AML

In brief

This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1.

Key facts

Study ID

NCT05428969

Run by

Faron Pharmaceuticals Ltd

People needed

181

Starts

2022-06-02

Expected to finish

2027-03-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient ≥ 18 years of age who presents with one of the following conditions:
• Morphologically confirmed diagnosis of MDS with revised International Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very high.
• Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine treatment.
• CMML and MDS patient with response failure to HMA or therapy regimen including HMA.
• Morphologically confirmed diagnosis of r/r AML following at least 1 line of prior therapies with indication for azacitidine treatment.
• Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
• Leukocyte count < 20 x10\^9/L (< 25 x10\^9/L for newly diagnosed AML). Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in CMML.
• Adequate renal function.
• Adequate liver function.

You may not qualify if…

• Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count > 13 x10\^9/L.
• Eastern Cooperative Oncology Group (ECOG) performance status >2 (except newly diagnosed AML where ECOG 3 is allowed for patients < 75 years).
• Allogeneic transplantation less than 6 months prior screening.
• Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
• The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment.
• Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than 14 days or five half-lives (whichever is shorter) from a small molecule targeted therapy or oral anticancer chemotherapy before the first study treatment.
• Any immunotherapy or investigational therapy within preceding 28 days from the first study treatment.
• Pregnant or lactating women.
• History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Helsinki University Hospital — Helsinki, Finland
• Kuopio University Hospital — Kuopio, Finland
• Oulu University Hospital — Oulu, Finland
• Tampere University Hospital — Tampere, Finland
• The Christie NHS Foundation Trust — Manchester, United Kingdom
• Royal Cornwall Hospitals NHS Trust — Truro, United Kingdom

Full record on ClinicalTrials.gov

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