Testing 6MW5311 in Adults With Blood Cancers That Returned or Did Not Respond
Tests 6MW5311 at rising doses in adults with relapsed or treatment-resistant leukemia or myeloma.
Plain-language title generated from the registry record
Registry title: Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Where in China
- Shanghai Jiao Tong University School of Medicine - Ruijin HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT07914556
- Record updated
- 3 November 2026
- Original description
To assess safety and tolerability at increasing dose levels of 6MW5311 in successive cohorts of participants with MM, AML and CMML in order to estimate the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) or the recommended expansion dose (RED).Read full original descriptionShow less
A Phase 1, Safety, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy Study of 6MW5311 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients, in Chronic Myelomonocytic Leukemia (CMML) Patients and Multiple Myeloma (MM) Patients
To assess safety and tolerability at increasing dose levels of 6MW5311 in successive cohorts of participants with MM, AML and CMML in order to estimate the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) or the recommended expansion dose (RED).
Inclusion: Age 18 years or older at the time of signing the informed consent form; male or female; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for the dose-escalation part, or 0 to 2 for the dose-expansion part; Life expectancy greater than 3 months; Multiple myeloma (MM): histologically and/or cytologically confirmed MM per International Myeloma Working Group (IMWG) 2016 criteria, with at least 3 prior lines of MM therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; Chronic myelomonocytic leukemia (CMML): morphologically confirmed by bone marrow examination per World Health Organization (WHO) 2016 classification, with relapsed disease or failure of prior therapy; Acute myeloid leukemia (AML; dose-expansion part only): morphologically confirmed acute myelomonocytic leukemia or acute monocytic leukemia per WHO 2016 classification, meeting the protocol definition of relapsed or refractory AML; MM only: measurable disease at screening; Adequate hematologic function at screening:; Able to understand and comply with the protocol requirements, willing to participate in the clinical study, and able to provide written informed consent.
Exclusion: 1. AML and CMML only: any other anticancer therapy within 2 weeks before the first dose of study drug; MM only: prior anticancer therapy within the following intervals before the first dose of study drug:; small-molecule targeted therapy within 4 weeks or 5 half-lives, whichever is shorter; antibody therapy within 3 weeks; cytotoxic chemotherapy, proteasome inhibitor therapy, or traditional Chinese medicine (including Chinese patent medicine) with an anticancer indication within 2 weeks; chimeric antigen receptor T-cell (CAR-T) therapy within 3 months; radiotherapy within 1 week. 2. Receipt of any other investigational drug within 4 weeks before the first dose of study drug; Prior allogeneic stem cell transplant; or autologous stem cell transplant within 3 months before the first dose of study drug; Planned stem cell transplant during the study. 5. Prior treatment with a LILRB4-targeted therapy; immunomodulatory agent within 1 week.