Acute Myeloid LeukemiaPhase 1/2NCT05448599
A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS
A Phase 1/2 study testing 6MW3211 injection with Intravenous Infusion in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- 6MW3211 injection with Intravenous Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2022to Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Hu Zhou, Ph.d, 13939068863, papertigerhu@163.com
About this study
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)
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.
Read the 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
- Being tested
- 6MW3211 injection with Intravenous Infusion
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MW3211 injection with Intravenous InfusionDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 6MW3211 | Experimental | 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) Receives: Drug: 6MW3211 injection with Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCR
Compound complete response rate
Measured: 1 year
ORR
Objective Response Rate
Measured: 1 year
phase II: safety
to evaluate the percentage of participants with adverse events and serious adverse events of 6MW3211 combination therapy in AML and MDS
Measured: Up to 28 days post last dose
Secondary outcomes (9)
AE
All the adverse events
Measured: Up to 28 days post last dose
DoCR
Duration of complete response
Measured: 1 year
RFS
Relapse-free survival
Measured: 1 year
EFS
Event-free survival
Measured: 1 year
OS
Overall survival
Measured: 1 year
PK Parameter
The area under the curve (AUC)
Measured: 1 year
Cmax
Maximum concentration
Measured: 1 year
Tmax
Time at which maximum concentration
Measured: 1 year
T1/2
The half life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start8 Jul 2022
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hu Zhou, Ph.D, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448599
- Sponsor's protocol ID
- 6MW3211-2022-CP102
- Status last verified
- Mar 2023
- First submitted
- 8 Jun 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05448599
- Acronym / sponsor ID
- 6MW3211-2022-CP102
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6MW3211 | Experimental | Drug: 6MW3211 injection with Intravenous InfusionPhase 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6MW3211 injection with Intravenous InfusionAlso: infusionphaseI: 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. | Drug | 6MW3211 |
Primary outcome
CCR
Time frame: 1 year
Compound complete response rate
ORR
Time frame: 1 year
Objective Response Rate
phase II: safety
Time frame: 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
9 secondary outcomes
AE
Time frame: Up to 28 days post last dose
DoCR
Time frame: 1 year
RFS
Time frame: 1 year
EFS
Time frame: 1 year
OS
Time frame: 1 year
PK Parameter
Time frame: 1 year
Cmax
Time frame: 1 year
Tmax
Time frame: 1 year
T1/2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Zhou, Ph.D principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 6MW3211 injection with Intravenous Infusion in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Zhou, Ph.D (13939068863, papertigerhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCR (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.