Trial · NCT07914556
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
NCT07914556, Phase 1, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers. Trials, record NCT07914556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
- NCT number
- NCT07914556
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 122 participants, estimated
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Conditions
- AML, Multiple Myeloma, CMML
- Interventions
- 6MW5311
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Secondary | Overall response rate (ORR) | 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. |
| Secondary | Maximum observed serum concentration (Cmax) of 6MW5311 | 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. |
| Secondary | Area under the serum concentration-time curve (AUC) of 6MW5311 | Through study completion, an average of 1 year | |
| Secondary | Time to maximum observed serum concentration (Tmax) of 6MW5311 | Through study completion, an average of 1 year | |
| Secondary | Terminal elimination half-life (t1/2) of 6MW5311 | Through study completion, an average of 1 year | |
| Secondary | Systemic clearance (CL) of 6MW5311 | Through study completion, an average of 1 year | |
| Secondary | Volume of distribution (V) of 6MW5311 | Through study completion, an average of 1 year |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07914556
GET https://conductscience.org/api/trials/v1/NCT07914556/registered