6MW5311 in adults with relapsed or refractory blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1 trial conducted in multiple centers. It has two parts: dose escalation to assess safety, tolerability, immunogenicity, pharmacokinetics/pharmacodynamics, biomarkers, and preliminary activity; and dose expansion to refine the recommended dose for Phase 2 based on Part 1 findings. The study will determine the maximum tolerated dose or the recommended expansion dose for hematologic malignancies. After Part 1, Part 2 will further evaluate safety, biomarker signals, and potential efficacy at selected doses. The sponsor is Mabwell (Shanghai) Bioscience, with sites at Shanghai Jiao Tong University School of Medicine, Ruijin Hospital in Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older at the time of signing the informed consent form; male or female.
2. 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.
3. Life expectancy greater than 3 months.
4. 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.
5. MM only: measurable disease at screening.
6. Adequate hematologic function at screening:
7. Able to understand and comply with the protocol requirements, willing to participate in the clinical study, and able to provide written informed consent.

Exclusion Criteria:

* 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;
* immunomodulatory agent within 1 week;
* 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.

  3\. Prior allogeneic stem cell transplant; or autologous stem cell transplant within 3 months before the first dose of study drug.

  4\. Planned stem cell transplant during the study. 5. Prior treatment with a LILRB4-targeted therapy.

Where it's running

• Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jiangjiang Lv
• Email: jiangjiang.lv@mabwell.com
• Phone: +86-021-58585793

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.