Clinical trial · Interventional
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)
NCT05448599CI-TRIAL-00064714unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6MW3211 injection with Intravenous Infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 6MW3211
- description
- 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)
- interventionNames
- Drug: 6MW3211 injection with Intravenous Infusion
Primary outcomes (3)
- measure
- CCR
- timeFrame
- 1 year
- description
- Compound complete response rate
- measure
- ORR
- timeFrame
- 1 year
- description
- Objective Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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；
References
Publications (0)
Data not yet available
No reference posted for this study.