{"commentary":{"count":11,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":6,"youtube":3,"podcast":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05428969\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"BEXMAB","nct_id":"NCT05428969","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bexmab-nct05428969. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"BEXMAB","arms":[{"description":"Standard of care azacitidine as per label; bexmarilimab 4 dose levels at once every week (Q1W) followed by once every 2 weeks (Q2W); 28-day cycle","label":"Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AML","type":"EXPERIMENTAL"},{"description":"Standard of care azacitidine and venetoclax as per label; bexmarilimab 4 dose levels Q1W followed by Q2W; 28-day cycle","label":"Phase 1 - Newly diagnosed AML patients non-fit for induction therapy","type":"EXPERIMENTAL"},{"description":"Standard of care venetoclax and/or azacitidine as per label plus bexmarilmab","label":"Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AML","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-03","type":"ESTIMATED"},"conditions":["Acute Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndromes","Relapsed/Refractory AML"],"enrollment":{"count":181,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Bexmarilimab","type":"DRUG"},{"name":"Azacitidine","type":"DRUG"},{"name":"Venetoclax","type":"DRUG"}],"last_update":"2026-04-23","lead_sponsor":"Faron Pharmaceuticals Ltd","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","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-03","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Reporting of incidence and frequency of dose limiting toxicities (DLTs).","timeFrame":"From study start to end of Cycle 1 (each cycle is 28 days)"},{"measure":"Frequency and severity based on NCI-CTCAE grading of treatment emergent AEs and serious adverse events (SAE).","timeFrame":"From study start to 30 days after end of treatment (EOT)"},{"measure":"Complete response (CR) rate for MDS and CMML-2.","timeFrame":"From study start to 30 days after EOT"},{"measure":"Overall response rate (ORR) for MDS and CMML failure to prior HMA.","timeFrame":"From study start to 30 days after EOT"},{"measure":"Complete remission with incomplete blood recovery (CRi) for r/r AML.","timeFrame":"From study start to 30 days after EOT"},{"measure":"Minimal residual disease (MRD) status for newly diagnosed AML.","timeFrame":"From study start to 30 days after EOT"}],"references":[{"citation":"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.","pmid":"40449509","type":"DERIVED"},{"citation":"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.","pmid":"40369178","type":"DERIVED"}],"start_date":{"date":"2022-06-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies","url":"https://clinicaltrials.gov/study/NCT05428969"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/bexmab-nct05428969"}