Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers

October 27, 2026 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 2-part, open-label, multicenter, First-in-Human Phase 1 clinical trial consisting of dose escalation (Part 1) and dose expansion (Part 2). Part 1 will evaluate the safety and tolerability, immunogenicity, PK/PD, biomarker, and preliminary clinical activities of 6MW5311. Part 2 will select appropriate dose(s) for expansion based on preliminary efficacy, safety, immunogenicity, PK/PD, and biomarkers data from Part 1, and will further assess the safety, PK, biomarker, and efficacy of 6MW5311. Upon completion of the Phase 1 clinical trial and findings from non-clinical studies, the recommended expansion dose (RED) or recommended Phase 2 dose (RP2D) of 6MW5311 in patients with hematological malignancies will be determined.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 - Dose Escalation (6MW5311)

A modified 3+3 design with accelerated titration will be used to evaluate planned dose levels.
Biological: 6MW5311

A bispecific T cell engager (TCE) antibody: bivalent binding to LILRB4 on tumor cells and monovalent binding to CD3 on T cells.
Experimental: Part 2 - Dose Expansion (6MW5311)

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.
Biological: 6MW5311

A bispecific T cell engager (TCE) antibody: bivalent binding to LILRB4 on tumor cells and monovalent binding to CD3 on T cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: From the first dose of Cycle 1 through Day 28 of Cycle 1 (each cycle is 28 days)

DLTs are adverse events considered related to 6MW5311 (definitely, probably, or possibly related) that occur during the dose-limiting toxicity observation period (first 28 days after the first dose of Cycle 1). DLTs are defined per the protocol and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
From the first dose of Cycle 1 through Day 28 of Cycle 1 (each cycle is 28 days)
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: From first dose through 28 days after the last dose, an average of 1 year

TEAEs will be graded per NCI CTCAE version 6.0 and coded by system organ class and preferred term.
From first dose through 28 days after the last dose, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: From first dose through end of treatment, an average of 1 year

ORR is the proportion of participants with a confirmed response. For multiple myeloma: the sum of confirmed stringent complete response, complete response, very good partial response, and partial response per International Myeloma Working Group (IMWG) 2016 criteria. For acute myeloid leukemia: the sum of confirmed complete response, complete remission with incomplete hematologic recovery, complete remission with partial hematologic recovery, morphologic leukemia-free state, and partial response per European LeukemiaNet (ELN) 2022 criteria. For chronic myelomonocytic leukemia: the sum of confirmed complete response, marrow response, partial response, and clinical benefit per the international MDS/MPN working group criteria.
From first dose through end of treatment, an average of 1 year
Maximum observed serum concentration (Cmax) of 6MW5311
Time Frame: Through study completion, an average of 1 year

Cmax is the maximum observed serum concentration of 6MW5311, read directly from the individual serum concentration-time profile after intravenous infusion.
Through study completion, an average of 1 year
Area under the serum concentration-time curve (AUC) of 6MW5311
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Time to maximum observed serum concentration (Tmax) of 6MW5311
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Terminal elimination half-life (t1/2) of 6MW5311
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Systemic clearance (CL) of 6MW5311
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Volume of distribution (V) of 6MW5311
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 19, 2026

First Submitted That Met QC Criteria

October 27, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 27, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6MW5311-CP101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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