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Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy | Clinical Trials | Clareo Health

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Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy

Single-Arm, Open Label, Interventional Phase II Clinical Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy

NCT03674411•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This is an single arm, open label, interventional phase II trial evaluating the efficacy of umbilical cord blood (UCB) hematopoietic stem and progenitor cells (HSPC) expanded in culture with stimulatory cytokines (SCF, Flt-3L, IL-6 and thromopoietin) on lympho-hematopoietic recovery. Patients will receive a uniform myeloablative conditioning and post-transplant immunoprophylaxis.

Eligibility

Age

0 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age, Unit Cell Dose and HLA Match Criteria
•Subjects must be ≤55 years of age
•Subjects must weigh \>11 kg
•Subjects must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose \>1.0 x 107 per kilogram recipient weight. HLA matching is initially based on a minimum of 5 of 8 HLA alleles at high resolution A, B, C, DRB1 typing; searches will be performed according to the current Magenta Cord Blood Search Algorithm.
•Eligible Diseases:
•Acute myelogenous leukemia (AML) in morphological complete remission with:
•* Minimal residual disease (MRD) by flow cytometry, or
•* Intermediate to high risk leukemia in first (CR1) based on institutional criteria, eg. not favorable risk AML which is defined as having one of the following:
•* t(8,21) without cKIT mutation
•* inv(16) or t(16;16) without cKIT mutation
+31 more criteria

Exclusion Criteria

•Patients with a HLA matched sibling donor or a HLA matched unrelated donor who is available for marrow or peripheral blood stem cell collection at the desired time of transplant.
•Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy.
•Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology.
•Active bacterial, viral or fungal infection (currently taking medication and persistence of clinical signs and symptoms) with a minimum of 4 weeks of anti-fungal treatment
•Prior autologous or allogeneic transplant.
•Other active malignancy.
•Subjects \>2 3 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.

Locations (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

January 2, 2019

Primary Completion Date

June 23, 2020

Completion Date

December 1, 2026

Last Updated

January 6, 2026

Enrollment

ACTUAL participants

Conditions

Acute Myeloid LeukemiaAcute Lymphocytic LeukemiaBiphenotypic/Undifferentiated LeukemiaChronic Myelogenous LeukemiaMyelodysplasiaRelapsed Large Cell LymphomaMantle Cell LymphomaHodgkin LymphomaBurkitt LymphomaRelapsed T-Cell LymphomaLymphoplasmacytic Lymphoma

Interventions

Fludarabine (FLU)

DRUG

Cyclophosphamide (CY)

DRUG

Total Body Irradiation (TBI)

DRUG

Tacrolimus (Tac)

DRUG

Mycophenolate Mofetil (MMF)

DRUG

Granulocyte Colony-Stimulating Factor (G-CSF)

DRUG

Busulfan (BU)

DRUG

Melphalan

DRUG

MGTA 456 Infusion

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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