NCT04762875

MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies

A Phase II Study Evaluating the Safety and Efficacy of MGTA-145 in Combination With Plerixafor for the Mobilization and Transplantation of HLA-Matched Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ensoma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.

Detailed description

This is a Phase II, open-label, multicenter, prospective study of MGTA-145 + plerixafor mobilized HLA-matched sibling and matched unrelated donor allografts for myeloablative hematopoietic stem cell transplantation (HSCT) in recipients with hematological malignancies. Donors will undergo 1 or 2 days of mobilization and apheresis.

Conditions

• Related Donors Donating PBSC to a Family Member
• Healthy Donors
• Acute Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	MGTA-145	MGTA-145 will be be administered as an IV infusion
BIOLOGICAL	Plerixafor	240 µg/kg subcutaneously

Timeline

• Start date: 2021-06-16
• Primary completion: 2021-09-14
• Completion: 2022-03-14
• First posted: 2021-02-21
• Last updated: 2024-11-06
• Results posted: 2024-08-29

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study