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Stem Cell Transplantation

MGTA-456 for High-Risk Cancer

Phase 2
Waitlist Available
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must weigh >11 kg
Subjects must be ≤55 years of age
Must not have
Other active malignancy
Subjects >23 years of age unable to receive TBI 1320 cGy due to extensive prior therapy including >12 months alkylator therapy or >6 months alkylator therapy with extensive radiation, or prior Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial is testing whether expanding stem cells from umbilical cord blood in culture with cytokines can improve lympho-hematopoietic recovery after a myeloablative conditioning.

Who is the study for?
This trial is for patients under 55 years old, weighing over 11 kg, with high-risk malignancies like various leukemias and lymphomas. They must have a partially matched umbilical cord blood unit for transplant and meet specific health criteria including good organ function and performance status. Pregnant women, those with HIV or other active cancers/infections, or previous transplants are excluded.
What is being tested?
The trial tests the effectiveness of expanded umbilical cord blood stem cells combined with a uniform myeloablative conditioning regimen (using drugs like Melphalan) and post-transplant immunoprophylaxis to improve recovery in patients with high-risk malignancies.
What are the potential side effects?
Potential side effects include reactions to the infusion such as fever or chills, risk of infections due to immune suppression from conditioning treatments, organ toxicity from chemotherapy drugs used in conditioning regimens (like liver or kidney issues), and graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 11 kilograms.
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I am 55 years old or younger.
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I have a partially matched cord blood unit for my transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another active cancer besides the one being treated.
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I am over 23 and can't have a specific radiation due to past intense treatments.
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I have a donor who matches my HLA type for a stem cell transplant.
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I have had a stem cell transplant from myself or a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Neutrophil Recover
Secondary study objectives
Chronic GVHD
Event-Free Survival (EFS)
Grades II-IV Acute GVHD
+8 more

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FLU, CY, TBI + MGTA-456 infusionExperimental Treatment9 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
FDA approved
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1220
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved
Filgrastim
FDA approved
Busulfan
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
281 Previous Clinical Trials
15,585 Total Patients Enrolled

Media Library

MGTA-456 Infusion (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03674411 — Phase 2
Acute Myeloid Leukemia Research Study Groups: FLU, CY, TBI + MGTA-456 infusion
Acute Myeloid Leukemia Clinical Trial 2023: MGTA-456 Infusion Highlights & Side Effects. Trial Name: NCT03674411 — Phase 2
MGTA-456 Infusion (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03674411 — Phase 2
~3 spots leftby Dec 2025
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