NCT04709458

Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis

A Phase I Study to Assess the Safety and Early Efficacy of TBX-2400 in Enhancing Engraftment in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Acute Myelogenous Leukemia or Myelofibrosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Taiga Biotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.

Conditions

• Myelofibrosis
• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	TBX-2400	Hematopoietic stem cells transplantation

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-08-28
• Completion: 2024-10-28
• First posted: 2021-01-14
• Last updated: 2022-05-03

Locations

2 sites across 2 countries: Croatia, Italy