Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05428969 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Faron Pharmaceuticals.

Active
Registry status
Phase 1
Development phase
181
Enrollment target
10
Study locations

NCT05428969 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Faron Pharmaceuticals. The registered enrollment target is 181 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% higher). The trial reports 10 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05428969, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Faron Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
181 participants
Enrollment target
10
Study locations

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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Relapsed/Refractory AML

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

3 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% higher). The listed sponsor is Faron Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT05428969 reports 10 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Connecticut.

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.

What interventions are being tested in trial NCT05428969?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Bexmarilimab (DRUG).

Who is sponsoring clinical trial NCT05428969?

This trial is sponsored by Faron Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Acute Myeloid Leukemia

All registered trials for this condition

Myelodysplastic Syndromes

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.