Study on the Safety and Effectiveness of Bexmarilimab Combined with Standard Treatment for Blood Cancers
Sponsor: Faron Pharmaceuticals Ltd
ClinicalTrials ID:NCT05428969
This clinical trial is testing the safety and potential benefits of a new drug, bexmarilimab, when used with standard treatments for certain blood cancers like MDS, CMML, and AML. The study aims to find the best dose and see how well the combination works.
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Program Overview
This study is exploring a new treatment involving bexmarilimab, a drug being tested for safety and effectiveness when combined with standard care for patients with certain blood cancers, including myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML). The first phase of the study will determine the safest dose of bexmarilimab, while the second phase will evaluate how well the treatment works in controlling the disease.
Description
This clinical trial is being conducted at multiple centers and is divided into two phases. In Phase 1, researchers will test different doses of bexmarilimab to find the safest and most tolerable dose when combined with standard treatments for patients with intermediate to very high-risk MDS, CMML with 10-19% marrow blasts, CMML/MDS that did not respond to previous treatments, or newly diagnosed AML that cannot be treated with standard induction therapy, as well as relapsed or refractory AML. The goal is to identify the maximum dose that patients can tolerate without severe side effects.
In Phase 2, the study will expand to further assess the safety and initial effectiveness of bexmarilimab at the recommended dose from Phase 1. This phase will focus on specific types of blood cancers that showed promise in the first phase. The study will include a screening period, a treatment period, and follow-up periods to monitor safety and disease progression.
Participants will be closely monitored throughout the study to ensure their safety and to evaluate how well the treatment is working. The study aims to provide valuable information on whether bexmarilimab can be a beneficial addition to standard treatments for these blood cancers.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and have one of the following conditions:
- Diagnosed with MDS with intermediate, high, or very high risk according to specific scoring systems.
- Diagnosed with CMML-2 and need treatment with azacitidine.
- Have CMML or MDS that did not respond to previous treatments including HMA.
- Diagnosed with relapsed or refractory AML after at least one prior treatment and need azacitidine treatment.
- Diagnosed with AML and unable to undergo standard induction therapy, needing azacitidine-venetoclax treatment.
- White blood cell count below specified levels (20 x10^9/L for most, 25 x10^9/L for newly diagnosed AML). Hydroxycarbamide can be used to meet this requirement for MDS and AML, but not for CMML.
- Must have adequate kidney and liver function.
Exclusion Criteria
- Have acute promyelocytic leukemia (APL) or a type of CMML with high white blood cell count (>13 x10^9/L).
- Have a performance status score greater than 2, except for newly diagnosed AML patients under 75 years old, where a score of 3 is allowed.
- Have had an allogeneic transplant within the last 6 months.
- Have an active autoimmune disorder, except for certain conditions like type I diabetes or hypothyroidism that only require hormone replacement.
- Require high doses of corticosteroids or other immunosuppressive treatments.
- Have received intravenous chemotherapy within the last 21 days, or small molecule or oral chemotherapy within the last 14 days or five half-lives, whichever is shorter.
- Have had immunotherapy or investigational therapy within the last 28 days.
- Are pregnant or breastfeeding.
- Have a history of chronic ulcers or severe liver disease.
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