Overview

A Clinical Study of 6MW3211 Injection to Treat Relapsed/Refractory AML or MDS

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study is aimed to evaluate the efficacy, safety, immunogenicity and pharmacodynamics of 6MW3211 injection in subjects with relapsed/refractory AML/MDS，and to find out appropriate dose level and dose interval for subsequent clinical studies.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Criteria
Inclusion Criteria:

- Voluntarily participate in the study and sign the informed consent;

- 18≤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;

Exclusion criteria:

- 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);

- Transformational or treatment-related MDS/AML;

- 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；