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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBX-2400 treatment | Experimental | Single intravenous infusion of TBX-2400 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBX-2400 | Biological | Hematopoietic stem cells transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events according to NCI-CTCAE Version 5.0 | Adverse events from subject reporting or other assessments | Two years |
| Transplant engraftment | Assessment of transplant engraftment will include absolute neutrophil count, untransfused platelet count and donor chimerism | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Immune reconstitution as measured by CD3+ cell count | Immune reconstitution as measured by CD3+ cell count > 300/μL | Up to Day 360 |
| Immunoglobulin (IgA) levels | Up to Day 360 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vivienne Margolis, B.Sc | Contact | +972-4639634 | vmargolis@taigabiotech.com | |
| Yosef Refaeli, Ph.D | Contact | +1-720-859-3547 | refaeli@taigabiotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Bacigalupo, MD | Unit for Hematology and BMT, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| D009196 | Myeloproliferative Disorders |
| D019046 | Bone Marrow Neoplasms |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
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| Immunoglobulin (IgM) levels | Up to Day 360 |
| T-cell Engraftment | CD45 RA versus RO at 3, 6, 9 and 12 months | Up to Day 360 |
| Disease-free survival | Two years |
| Incidence of secondary graft failure | Two years |
| Transplant-Related Mortality (TRM) | 100 Days |
| Quality of life using the World Health Organisation Five Wellbeing Index | QoL assessed at 3, 6, 9 and 12 months (World Health Organization [WHO] Five Wellbeing Index). | Up to day 360 |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |