Clinical trial · no report yet · Phase 1/Phase 2
BEXMAB
A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies
- NCT05428969 ↗
- Active not recruiting
- Faron Pharmaceuticals Ltd
- 11 commentary sources found
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 6 | |
| YouTube | 3 | |
| Podcasts | 2 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 1/Phase 2
- Status
- Active not recruiting
- Conditions
- Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Relapsed/Refractory AML
- Interventions
- Bexmarilimab; Azacitidine; Venetoclax
- Arms
- Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AML · Experimental
- Phase 1 - Newly diagnosed AML patients non-fit for induction therapy · Experimental
- Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AML · Experimental
- Enrollment
- 181 (estimated)
- Primary outcomes
- Reporting of incidence and frequency of dose limiting toxicities (DLTs).
- Frequency and severity based on NCI-CTCAE grading of treatment emergent AEs and serious adverse events (SAE).
- Complete response (CR) rate for MDS and CMML-2.
- Overall response rate (ORR) for MDS and CMML failure to prior HMA.
- Complete remission with incomplete blood recovery (CRi) for r/r AML.
- Minimal residual disease (MRD) status for newly diagnosed AML.
- Sponsor
- Faron Pharmaceuticals Ltd
- Start
- Jun 2, 2022
- Primary completion
- Mar 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05428969 · updated Apr 23, 2026
Publications
linked from the registry- Kontro M, Stein AS, Pyorala M, Rimpilainen J, Siitonen T, Ylitalo A, Fjallskog ML, Jalkanen J, Aakko S, Pawlitzky I, Hollmen M, Daver N. Bexmarilimab plus azacitidine for high-risk myelodysplastic syndrome and relapsed or refractory acute myeloid leukaemia: results from the dose-escalation part of a multicentre, single-arm, phase 1/2 trial. Lancet Haematol. 2025 Jul;12(7):e516-e528. doi: 10.1016/S2352-3026(25)00103-6. Epub 2025 May 28. PubMed 40449509
- Aakko S, Ylitalo A, Kuusanmaki H, Rannikko JH, Bjorkman M, Mandelin J, Heckman CA, Kontro M, Hollmen M. CLEVER-1 targeting antibody, bexmarilimab, supports HLA-DR expression and alters ex vivo responsiveness to azacitidine and venetoclax in myeloid malignancies. Sci Rep. 2025 May 14;15(1):16775. doi: 10.1038/s41598-025-01675-y. PubMed 40369178