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

NCT04709458 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-03

No results posted yet for this study

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

Interventions

BIOLOGICAL

TBX-2400

Hematopoietic stem cells transplantation

Sponsors & Collaborators

  • Taiga Biotechnologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Bacigalupo, MD · Unit for Hematology and BMT, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-08-28
Completion
2024-10-28

Countries

  • Croatia
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709458 on ClinicalTrials.gov