๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-20

A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies (NCT05428969)

A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination With Standard of Care Therapy in Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Faron Pharmaceuticals Ltd

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: City of Hope National Medical Center โ€” Duarte, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

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

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—