A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS
- Conditions
- Myelodysplastic SyndromeAcute Myeloid Leukemia
- Interventions
- Drug: 6MW3211 injection with Intravenous Infusion
- Registration Number
- NCT05448599
- Lead Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- 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.
- Detailed Description
This study is a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of 6MW3211 monotherapy or combined with AZA or AZA plus VEN in patients with AML and MDS. There will be 2 parts of this study. The phase Ib is about monotherapy of 6MW3211 and Phase II is designed to evaluate the safety and efficacy of 6MW3211 combined with AZA or AZA plus VEN in patients with relapse/refractory and newly diagnosed AML and MDS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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; 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
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);
- 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；
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 6MW3211 6MW3211 injection with Intravenous Infusion 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)
- Primary Outcome Measures
Name Time Method CCR 1 year Compound complete response rate
ORR 1 year Objective Response Rate
phase II: safety Up to 28 days post last dose to evaluate the percentage of participants with adverse events and serious adverse events of 6MW3211 combination therapy in AML and MDS
- Secondary Outcome Measures
Name Time Method RFS 1 year Relapse-free survival
Tmax 1 year Time at which maximum concentration
AE Up to 28 days post last dose All the adverse events
PK Parameter 1 year The area under the curve (AUC)
EFS 1 year Event-free survival
OS 1 year Overall survival
DoCR 1 year Duration of complete response
Cmax 1 year Maximum concentration
T1/2 1 year The half life
Trial Locations
- Locations (1)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China