NCT03674411

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia
• Biphenotypic/Undifferentiated Leukemia
• Chronic Myelogenous Leukemia
• Myelodysplasia
• Relapsed Large Cell Lymphoma
• Mantle Cell Lymphoma
• Hodgkin Lymphoma
• Burkitt Lymphoma
• Relapsed T-Cell Lymphoma
• Lymphoplasmacytic Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine (FLU)	25 mg/m2 IV over 1 hour (\<10 kg: 0.83 mg/kg IV over 1 hour)
DRUG	Cyclophosphamide (CY)	60 mg/kg IV over 2 hours
DRUG	Total Body Irradiation (TBI)	165 cGy twice daily
DRUG	Tacrolimus (Tac)	Tacrolimus will start day -3 and will be administered as a continuous IV infusion at a starting dose of 0.03 mg/kg/day. Goal trough levels will be 10-15 ng/mL for the first 14 days post-transplant and then decreased to a goal of 5-10 ng/ml thereafter.
DRUG	Mycophenolate Mofetil (MMF)	MMF 3 gram/day IV/PO for adult patients divided in 2 or 3 doses. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (max 1 gram per dose) every 8 hours beginning day -3.
DRUG	Granulocyte Colony-Stimulating Factor (G-CSF)	5 ug/kg/d until the absolute neutrophil count (ANC) is \>2500/uL for 2 consecutive days
DRUG	Busulfan (BU)	BU IV once daily with dose based on Pharmacokinetics (PK) calculator over 3 hours
DRUG	Melphalan	50 mg/m2/day (1.7 mg/kg/day if \< 10 kg) IV over 30 min
DRUG	MGTA 456 Infusion	The target cell dose is \>10 x 106 CD34/kg with a maximum TNC 2.7 x 108/kg for children (\<18 years) and 8.1 × 108 cells/kg \[expanded product only\] for adults based on the highest cell dose windows evaluated in prior studies.

Timeline

• Start date: 2019-01-02
• Primary completion: 2020-06-23
• Completion: 2026-12-01
• First posted: 2018-09-17
• Last updated: 2026-01-06
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study