NCT05448599

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

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-08
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2022-07-07
• Last updated: 2023-03-15

Locations

1 site across 1 country: China