ACTIVE_NOT_RECRUITING

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

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Conditions

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromesRelapsed/Refractory AMLMacrophagesImmunotherapyHematologicalCLEVER-1bexmarilimabhematological neoplasmsazacitidinevenetoclaxmyeloid cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-02
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05428969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient ≥ 18 years of age who presents with one of the following conditions:
  2. * Morphologically confirmed diagnosis of MDS with revised International Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very high.
  3. * Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine treatment.
  4. * CMML and MDS patient with response failure to HMA or therapy regimen including HMA.
  5. * Morphologically confirmed diagnosis of r/r AML following at least 1 line of prior therapies with indication for azacitidine treatment.
  6. * Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
  7. * 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.
  8. * Adequate renal function.
  9. * Adequate liver function.
  1. * Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count \> 13 x10\^9/L.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status \>2 (except newly diagnosed AML where ECOG 3 is allowed for patients \< 75 years).
  3. * Allogeneic transplantation less than 6 months prior screening.
  4. * Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
  5. * The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment.
  6. * 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.
  7. * Any immunotherapy or investigational therapy within preceding 28 days from the first study treatment.
  8. * Pregnant or lactating women.
  9. * History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.

Contacts and Locations

Principal Investigator

Mika Kontro, MD, PhD
PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Faron Pharmaceuticals Ltd

  • Mika Kontro, MD, PhD, PRINCIPAL_INVESTIGATOR, Helsinki University Central Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-02
Study Completion Date2026-04

Study Record Updates

Study Start Date2022-06-02
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Macrophages
  • Immunotherapy
  • Hematological
  • CLEVER-1
  • bexmarilimab
  • hematological neoplasms
  • azacitidine
  • venetoclax
  • myeloid cells

Additional Relevant MeSH Terms

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