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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 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

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 more
Secondary 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 more

Side effects data

From 2022 Phase 2 trial • 25 Patients • NCT04552743
52%
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

Find a Location

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

Frequently Asked Questions

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

Is this clinical research open to octogenarian participants?

"Based on the standards set forth by this medical trial, prospective participants must be at least 18 years old and no older than 35."

Answered by AI

Is enrollment for this trial still accessible to interested participants?

"This research study, which was initially advertised on June 24th 2022, is actively enrolling participants. The trial information has recently been updated as of November 4th 2022."

Answered by AI

What is the participant limit for this clinical trial?

"Affirmative, clinicaltrials.gov shows that the trial is actively enrolling participants since its launch on June 24th 2022 and last update on November 4th 2022. In total, 14 patients are needed from 3 different sites."

Answered by AI

Has the regulatory agency sanctioned MGTA-145?

"With the existing clinical evidence supporting MGTA-145's safety, our team at Power awarded it a score of 2 on a scale from 1 to 3. This is due to this being in Phase 2 trials, indicating there is no data yet for efficacy."

Answered by AI

What criteria must be met for someone to qualify for this clinical investigation?

"This investigation is open to 14 people aged 18-35 with sickle cell anemia. In order to be considered eligible, applicants must possess a valid diagnosis of Sickle Cell Disease, weigh at least 30 kg and fall within the specified age range."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease
2022. "Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445128.
~0 spots leftby Apr 2025
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