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Monoclonal Antibodies

MBG453 for Myelodysplastic Syndrome

Phase 2

Recruiting

Led By Andrew Brunner, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is looking at whether or not MBG-453 is effective in treating myelodysplastic syndromes (MDS).

Who is the study for?

This trial is for adults with lower risk Myelodysplastic Syndromes (MDS) who need regular red blood cell transfusions, have not responded to previous treatments, or can't tolerate other medications. It's also open to those with specific genetic changes in their MDS and no available standard treatment options.Check my eligibility

What is being tested?

The study is testing MBG453, a humanized monoclonal antibody designed to treat MDS. Researchers want to see how effective it is at improving the condition of patients who haven't had success with other therapies.See study design

What are the potential side effects?

While the side effects of MBG453 are not detailed here, as a monoclonal antibody, potential side effects could include allergic reactions, infusion-related symptoms like fever or chills, fatigue, and possible impacts on liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Duration of response

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

Overall survival (OS) 1-year

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MG MBG453Experimental Treatment1 Intervention

Participants will be given MBG453 On Day 1 of each cycle 28 days (4 weeks) study cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sabatolimab

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,425 Total Patients Enrolled

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,721,015 Total Patients Enrolled

Andrew Brunner, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

41 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for individuals to participate in the trial?

"Unfortunately, the trial is not currently open to new patients. Initially shared on September 1st 2021 and last updated March 28th of this year, no more participants are being accepted at present. Nevertheless, 432 clinical trials for myelodysplastic syndromes as well as 12 studies pertaining to MBG453 remain active and eager for volunteers."

Answered by AI

How many people are part of this medical research experiment?

"This research project is not currently open for participation. The protocol was initially posted on September 1st 2021 and last edited on March 28th 2021. Those looking to participate in other studies may be interested to know that 432 clinical trials are actively admitting patients with myelodysplastic syndromes, and there are 12 trails for MBG453 enrolling participants at this time."

Answered by AI

Does this investigation represent an unprecedented research endeavor?

"Since 2017, MBG453 has been subject to an array of clinical investigations. Its first trial was sponsored by Novartis Pharmaceuticals and included 243 respondents. Following its success, it earned approval in Phase 1 drug trials; at present there are 12 active studies involving 133 cities across 42 countries."

Answered by AI

Have prior research projects included MBG453?

"Presently, 12 investigations into MBG453 have been initiated with 1 trial at Phase 3. Toon-city in Ehime hosts the most clinical trials for MBG453 yet there are 379 other sites worldwide also exploring its properties."

Answered by AI

How have the safety assessments of MBG453 been evaluated?

"MBG453's safety has been partially established, leading to a rating of 2. This is because the drug is currently undergoing Phase 2 trials and there exists some evidence for its security but none that confirms efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MBG453 in Lower Risk MDS

Andrew Mark Brunner, MD 2022. "MBG453 in Lower Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04823624.

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