Clinical trial NCT05448599: A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS
Official title: A Study to Evaluate Pharmcokinetics, Pharmacodynamics , Efficacy and Safety of 6MW3211 Monotherapy and in Combination With Azacitidine(AZA) or AZA Plus Venetoclax(VEN) in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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; 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；

Primary outcomes:
measure: CCR
timeFrame: 1 year
measure: ORR
timeFrame: 1 year
measure: phase II: safety
timeFrame: Up to 28 days post last dose
Secondary outcomes:
measure: AE
timeFrame: Up to 28 days post last dose
measure: DoCR
timeFrame: 1 year
measure: RFS
timeFrame: 1 year
measure: EFS
timeFrame: 1 year
measure: OS
timeFrame: 1 year
measure: PK Parameter
timeFrame: 1 year
measure: Cmax
timeFrame: 1 year
measure: Tmax
timeFrame: 1 year
measure: T1/2
timeFrame: 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Hu Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: