RecruitingPhase 1interventionalRules rewrite

Phase 1: testing 6MW5311 for AML

To assess whether it is safe and how hard side effects are to live with 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).

Official registry: https://clinicaltrials.gov/study/NCT07914556 · Mabwell (Shanghai) Bioscience Co., Ltd. · enrollment listed as 122

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 6MW5311. The registry lists allocation as randomized. To assess whether it is safe and how hard side effects are to live with 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).

They plan to enroll about 122 people at Shanghai. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: 6MW5311

Primary outcome (registry wording): Number of participants with dose-limiting toxicities (DLTs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
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:

Who the registry excludes

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;

Public study contact (from the registry)

Jiangjiang Lv

+86-021-58585793

jiangjiang.lv@mabwell.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital — Shanghai, Shanghai Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT07914556 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07914556?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07914556?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary