NCT05448599

Brief Summary

This study is aimed to evaluate the efficacy, safety, immunogenicity and pharmkinetics, pharmacodynamics of 6MW3211 as monotherapy and in combination with AZA or AZA plus VEN in patients with AML/MDS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

June 8, 2022

Last Update Submit

March 13, 2023

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Outcome Measures

Primary Outcomes (3)

  • CCR

    Compound complete response rate

    1 year

  • ORR

    Objective Response Rate

    1 year

  • phase II: safety

    to evaluate the percentage of participants with adverse events and serious adverse events of 6MW3211 combination therapy in AML and MDS

    Up to 28 days post last dose

Secondary Outcomes (9)

  • AE

    Up to 28 days post last dose

  • DoCR

    1 year

  • RFS

    1 year

  • EFS

    1 year

  • OS

    1 year

  • +4 more secondary outcomes

Study Arms (1)

6MW3211

EXPERIMENTAL

Phase I, 6MW3811 monotherapy in 2 dose levels of 30mg/kg or 45mg/kg; phase II, 6MW3811 will be given in combination with AZA( cohort1) and AZA plus VEN(cohort 2)

Drug: 6MW3211 injection with Intravenous Infusion

Interventions

6MW3211 injection with Intravenous InfusionDRUG

phaseI: 6MW3211 will be administered in 30mg/kg and 45mg/kg intravenously once every 2 weeks; phaseII: 6MW3211 will be administered in 45mg/kg intravenously in both 2 cohorts.AZA will be administered in 75mg/m2 by subcoutaneous injection in cohort 1 as well as cohort 2 from Day1-Day7 every 28-day cycle. VEN will be administered orally with dose escalation to 400mg daily every cycle.

Also known as: infusion
6MW3211

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate in the study and sign the informed consent;
  • ≤age≤75，Men or women；
  • AML patients (except acute promyelocytic leukemia) : subjects who meet the diagnostic criteria for relapsed/refractory AML according to the diagnostic criteria of 2021 Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory AML ； MDS patients: MDS patients were diagnosed as having moderate risk of recurrence/refractory (IPSS-R score \>3.5) according to WHO diagnostic criteria in 2016
  • ECOG:0-2;
  • Survival expectation of at least 3 months;
  • Adequate organs and hematopoietic functions; only applicable for phase II :
  • Newly diagnosed AML with intolerance to standard induction chemotherapy who should meet one of following criterias: age ≥75 years; ECOG 2-3; chronic heart failure requiring treatment or EF≤50% or chronic stable angina pectoris; DLCO≤65% or FEV1≤65%;30ml/min≤CrCl\<45ml/min；1.5 x ULN\<total bilirubin≤3.0 x ULN
  • Newly diagnosed intermediate- and high-risk (International Prognostic Scoring System IPSS-R) MDS

You may not qualify if:

  • Myeloid proliferative diseases (MPN), including primary myelofibrosis (PMF), polycythemia vera (PV), chronic myelogenous leukemia (CML), and primary thrombocytopenia (ET); Or have myelodysplastic myeloid proliferative tumors (MDS-MPN), including chronic monocytic leukemia (CMML), atypical chronic myelogenous leukemia (aCML), juvenile granulomatous single-cell leukemia (JMML), and acute promyelocytic leukemia (M3);
  • Recurrence after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year;
  • Known infiltration of central nervous system leukemia；
  • Active or uncontrolled autoimmune diseases；
  • Has a history of other malignancies；
  • Has known inherited or acquired hemorrhagic disorders；
  • Pregnant or lactating women；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • Hu Zhou, Ph.D

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu Zhou, Ph.D

CONTACT

13939068863papertigerhu@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

July 7, 2022

Study Start

July 8, 2022

Primary Completion

June 1, 2024

Study Completion

October 1, 2024

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)