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ACTIVE NOT RECRUITING Phase 1

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

NCT05428969 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Bexmarilimab

Study Locations (10)

Other

  • Helsinki University Hospital — Helsinki
  • Kuopio University Hospital — Kuopio
  • Oulu University Hospital — Oulu
  • Tampere University Hospital — Tampere
  • The Christie NHS Foundation Trust — Manchester
  • Royal Cornwall Hospitals NHS Trust — Truro

California

  • City of Hope National Medical Center — Duarte

Connecticut

  • Yale Cancer Center — New Haven

North Carolina

  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill

Texas

  • University of Texas, MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2022-06-02
Est. Completion 2026-04
Phase Phase 1

Sponsor

Faron Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05428969

The ClinicalTrials.gov registry entry for NCT05428969 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Faron Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05428969 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05428969 about?

NCT05428969 is a clinical study titled "A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies". 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 (R...

What is the current status of trial NCT05428969?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 181 participants. The study started on 2022-06-02. Estimated completion is 2026-04.

What conditions does trial NCT05428969 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Relapsed/Refractory AML. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05428969?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Bexmarilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05428969?

This trial is sponsored by Faron Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05428969 being conducted?

This trial has 10 study locations across California, Connecticut, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial