A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS

Acute Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448599
• Other study ID #: 6MW3211-2022-CP102
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 8, 2022
• Est. completion date: October 2024

Study information

• Verified date: March 2023
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: Hu Zhou, Ph.D
• Phone: 13939068863
• Email: papertigerhu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• 6MW3211 injection with Intravenous Infusion
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.

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCR	Compound complete response rate	1 year
Primary	ORR	Objective Response Rate	1 year
Primary	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	AE	All the adverse events	Up to 28 days post last dose
Secondary	DoCR	Duration of complete response	1 year
Secondary	RFS	Relapse-free survival	1 year
Secondary	EFS	Event-free survival	1 year
Secondary	OS	Overall survival	1 year
Secondary	PK Parameter	The area under the curve (AUC)	1 year
Secondary	Cmax	Maximum concentration	1 year
Secondary	Tmax	Time at which maximum concentration	1 year
Secondary	T1/2	The half life	1 year