Clinical Trials in China / NCT07914556
Recruiting
Phase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
NCT07914556 · tracked via the Priya Life Science China tracker
Condition(s) studied
AMLMultiple MyelomaCMML
Investigational drug(s) / intervention(s)
6MW5311
6MW5311: A bispecific T cell engager (TCE) antibody: bivalent binding to LILRB4 on tumor cells and monovalent binding to CD3 on T cells.
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Number of participants with dose-limiting toxicities (DLTs) — 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) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine, Ruijin Hospital | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07914556 on ClinicalTrials.gov ↗ ← All trials in China