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.
Key facts
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 122 people, planned
- Started
- 16 Sept 2026
- Expected to end
- Dec 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- 6MW5311
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma, chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) that came back or did not respond to earlier treatment. It tests the study drug 6MW5311.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Multiple myeloma: confirmed disease with measurable disease at screening. CMML: disease that came back or did not respond to earlier treatment. AML (dose-expansion part only): acute myelomonocytic or acute monocytic leukemia that came back or did not respond to treatment.
- Earlier treatment
- Multiple myeloma: at least 3 earlier lines of treatment, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. Cannot have had earlier treatment against LILRB4, a donor stem cell transplant, or another trial drug within 4 weeks.
Main reasons for not taking part
- Earlier treatment against LILRB4
- Earlier stem cell transplant from a donor
- Own stem cell transplant within 3 months before the first dose
- Planned stem cell transplant during the study
- Any other trial drug within 4 weeks before the first dose
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in China
- Shanghai Jiao Tong University School of Medicine - Ruijin HospitalShanghai, ChinaContact: Jianqing Mi, PhDTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Part 1 - Dose Escalation (6MW5311)Treatment being tested
A modified 3+3 design with accelerated titration will be used to evaluate planned dose levels.
Treatment: 6MW5311
- Part 2 - Dose Expansion (6MW5311)Treatment being tested
Participants with chronic myelomonocytic leukemia (CMML), multiple myeloma (MM), or relapsed or refractory acute myeloid leukemia (AML; acute myelomonocytic or monocytic subtypes) will receive 6MW5311 at the dose level(s) selected by the Safety Review Committee from Part 1.
Treatment: 6MW5311
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Testing 6MW5311 in Adults With Blood Cancers That Returned or Did Not RespondGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 3 November 2026