drugset
drugset / Trial / NCT03674411

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

NCT03674411 ↗

Phase 2 Active not recruiting 22 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-01-02
Primary completion
2020-06-23
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HSC835 Cell therapy 1e+07 cells/kg Other
Background Busulfan Small molecule — Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 0.83 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 5 ug/kg —
Background Melphalan Small molecule 1.7 mg/kg Intravenous
Background Melphalan Small molecule 50 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 3 g Intravenous
Background Tacrolimus Small molecule 0.03 mg/kg Intravenous

Indications

Burkitt lymphoma Hodgkins lymphoma T-cell non-Hodgkin lymphoma acute biphenotypic leukemia chronic myeloid leukemia large B-cell lymphoma lymphoplasmacytic lymphoma mantle cell lymphoma myelodysplastic syndrome