AMLPhase 1NCT07914556
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
A Phase 1 study testing 6MW5311 in people with AML and Multiple Myeloma, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Multiple Myeloma, CMML
- What is being tested?
- 6MW5311
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Jianqing Mi, PhD, +86-13524488296, jianqingmi@shsmu.edu.cn
About this study
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
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 the 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.
- Conditions
- AML, Multiple Myeloma, CMML
- Being tested
- 6MW5311
- Keywords
- LILRB4, CD3, TCE
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MW5311Biological
A bispecific T cell engager (TCE) antibody: bivalent binding to LILRB4 on tumor cells and monovalent binding to CD3 on T cells.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Dose Escalation (6MW5311) | Experimental | A modified 3+3 design with accelerated titration will be used to evaluate planned dose levels. Receives: Biological: 6MW5311 |
| Part 2 - Dose Expansion (6MW5311) | Experimental | 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. Receives: Biological: 6MW5311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs)
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.
Measured: 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)
TEAEs will be graded per NCI CTCAE version 6.0 and coded by system organ class and preferred term.
Measured: From first dose through 28 days after the last dose, an average of 1 year
Secondary outcomes (7)
Overall response rate (ORR)
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.
Measured: From first dose through end of treatment, an average of 1 year
Maximum observed serum concentration (Cmax) of 6MW5311
Cmax is the maximum observed serum concentration of 6MW5311, read directly from the individual serum concentration-time profile after intravenous infusion.
Measured: Through study completion, an average of 1 year
Area under the serum concentration-time curve (AUC) of 6MW5311
Measured: Through study completion, an average of 1 year
Time to maximum observed serum concentration (Tmax) of 6MW5311
Measured: Through study completion, an average of 1 year
Terminal elimination half-life (t1/2) of 6MW5311
Measured: Through study completion, an average of 1 year
Systemic clearance (CL) of 6MW5311
Measured: Through study completion, an average of 1 year
Volume of distribution (V) of 6MW5311
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start16 Sep 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914556
- Sponsor's protocol ID
- 6MW5311-CP101
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07914556
- Acronym / sponsor ID
- 6MW5311-CP101
- Conditions
- AML, Multiple Myeloma, CMML
- Keywords
- LILRB4, CD3, TCE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Dose Escalation (6MW5311) | Experimental | Biological: 6MW5311A modified 3+3 design with accelerated titration will be used to evaluate planned dose levels. |
| Part 2 - Dose Expansion (6MW5311) | Experimental | Biological: 6MW5311Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- MM only: measurable disease at screening.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6MW5311A bispecific T cell engager (TCE) antibody: bivalent binding to LILRB4 on tumor cells and monovalent binding to CD3 on T cells. | Biological | Part 1 - Dose Escalation (6MW5311), Part 2 - Dose Expansion (6MW5311) |
Primary outcome
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.
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.
7 secondary outcomes
Overall response rate (ORR)
Time frame: 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
Area under the serum concentration-time curve (AUC) of 6MW5311
Time frame: 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
Terminal elimination half-life (t1/2) of 6MW5311
Time frame: Through study completion, an average of 1 year
Systemic clearance (CL) of 6MW5311
Time frame: Through study completion, an average of 1 year
Volume of distribution (V) of 6MW5311
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 6MW5311 in people with AML and Multiple Myeloma, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiangjiang Lv (+86-021-58585793, jiangjiang.lv@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.