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Monoclonal Antibodies

MBG453 for Preleukemia

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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Secondary study objectives
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

Side effects data

From 2024 Phase 2 trial • 127 Patients • NCT03946670
47%
Constipation
42%
Diarrhoea
37%
Neutropenia
32%
Anaemia
29%
Thrombocytopenia
24%
Nausea
24%
Pyrexia
24%
Febrile neutropenia
23%
Fatigue
21%
Decreased appetite
21%
White blood cell count decreased
19%
Neutrophil count decreased
19%
Platelet count decreased
19%
Rash
18%
Dyspnoea
18%
Pain in extremity
18%
Hypokalaemia
16%
Back pain
16%
Pruritus
15%
Asthenia
15%
Weight decreased
13%
Cough
13%
Headache
13%
Urinary tract infection
13%
Pneumonia
13%
Oedema peripheral
13%
Dizziness
13%
Insomnia
13%
Epistaxis
11%
Arthralgia
11%
Hypertension
10%
Haemorrhoids
10%
Aspartate aminotransferase increased
10%
Vomiting
10%
Myalgia
10%
COVID-19
10%
Contusion
10%
Hypoalbuminaemia
10%
Erythema
10%
Night sweats
8%
Atrial fibrillation
8%
SARS-CoV-2 test negative
8%
Acute kidney injury
8%
Abdominal pain
8%
Oropharyngeal pain
6%
Alanine aminotransferase increased
6%
Hyperglycaemia
6%
Haematuria
6%
Stomatitis
6%
Hyponatraemia
6%
Blood alkaline phosphatase increased
6%
Injection site reaction
6%
Herpes zoster
6%
Procedural pain
6%
Hyperuricaemia
6%
Paraesthesia
6%
Dysuria
6%
Haematoma
5%
Sepsis
5%
Blood lactate dehydrogenase increased
5%
Lymphocyte count decreased
5%
Pain
3%
Septic shock
3%
Oral herpes
3%
Transfusion reaction
3%
Gamma-glutamyltransferase increased
3%
Blood creatinine increased
3%
Injection site erythema
3%
Cellulitis
3%
Respiratory tract infection
3%
Oedema
3%
Hyperkalaemia
3%
Hypernatraemia
3%
Purpura
3%
Hypotension
2%
Cardiac arrest
2%
Pseudomonal bacteraemia
2%
Lung disorder
2%
Anal haemorrhage
2%
Haemoglobin decreased
2%
Pathological fracture
2%
Lip squamous cell carcinoma
2%
Peripheral sensory neuropathy
2%
Metastases to bone
2%
General physical condition abnormal
2%
Conjunctival haemorrhage
2%
Escherichia bacteraemia
2%
Pleural effusion
2%
Pneumonitis
2%
Chest pain
2%
Blood bilirubin increased
2%
Hypomagnesaemia
2%
Gastrointestinal bacterial infection
2%
Peripheral artery stenosis
2%
Pancreatitis acute
2%
Bronchopulmonary aspergillosis
2%
Abdominal pain upper
2%
Dermo-hypodermitis
2%
Squamous cell carcinoma of the hypopharynx
2%
Cerebral haemorrhage
2%
Hyperleukocytosis
2%
Staphylococcal infection
2%
Urosepsis
2%
Fall
2%
Febrile nonhaemolytic transfusion reaction
2%
Infusion related reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
MBG453 + Hypomethylating Agents
Placebo + Hypomethylating Agents

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,701 Total Patients Enrolled
NovartisIndustry Sponsor
1,624 Previous Clinical Trials
2,723,762 Total Patients Enrolled
Andrew Brunner, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
41 Total Patients Enrolled
~6 spots leftby Sep 2025
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