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Stem Cell Mobilizer
MGTA-145 for Sickle Cell Disease
Phase 2
Waitlist Available
Research Sponsored by Magenta Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study Summary
This trial will test a new potential medicine, MGTA-145, for sickle cell disease. It will be given with plerixafor, and the goal is to see if it can help mobilize stem cells and improve apheresis collection.
Eligible Conditions
- Sickle Cell Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apheresis Collection Yield
Assess incidence of treatment emergent adverse events leading to study drug discontinuation based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Assess the incidence of treatment emergent >/= Grade 3 clinical laboratory abnormalities based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
+2 moreSecondary outcome measures
Assess presence of MGTA-145 Anti-Drug Antibodies (ADA) in plasma samples (using electrochemiluminescent immunoassay [ECLIA])
Assess titers of MGTA-145 Anti-Drug Antibodies (ADA) in plasma samples (using electrochemiluminescent immunoassay [ECLIA])
Investigate plasma concentrations of MGTA-145 per timepoint of collection (Pharmacokinetics)
+1 moreSide effects data
From 2022 Phase 2 trial • 25 Patients • NCT0455274352%
Pain
28%
Paresthesia
24%
Nausea
20%
Platelet count decreased
20%
Hypocalcemia
12%
Anemia
12%
Hypokalemia
8%
Vomiting
8%
Headache
8%
Oral dysesthesia
4%
Other - Poor Graft Function (anemia, neutropenia, thrombocytopenia)
4%
Diarrhea
4%
Constipation
4%
Aspartate aminotransferase increased
4%
Alanine aminotransferase increased
4%
Dizziness
4%
Hot flashes
4%
Insomnia
4%
Urinary frequency
4%
Hyperhidrosis
4%
Fatigue
4%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
MGTA-145 and Plerixafor HSC Mobilization
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: 2-Day Dosing/ApheresisExperimental Treatment2 Interventions
MGTA-145 in combination with plerixafor followed by apheresis on two consecutive days
Group II: Part A: Single Day Dosing/ApheresisExperimental Treatment2 Interventions
Single dose of MGTA-145 in combination with plerixafor followed by apheresis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MGTA-145
2019
Completed Phase 2
~160
Plerixafor
FDA approved
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Who is running the clinical trial?
Magenta Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
170 Total Patients Enrolled
EnsomaLead Sponsor
3 Previous Clinical Trials
137 Total Patients Enrolled
bluebird bioIndustry Sponsor
20 Previous Clinical Trials
2,042 Total Patients Enrolled
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