A Phase 1 Non-Randomized, Open-Label/Phase 2 Randomized, Blinded Study of ProTmune (ex vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects with Hematologic Malignancies
This study consists of two consecutive phases, Phase 1 and Phase 2.
The purpose of Phase 1 is to test the effects, good and/or bad, of ProTmune (study drug) on participants receiving hematopoietic cell transplantations with the study drug. The study drug is a product prepared from the blood cells that are collected from a matched unrelated donor.
The purpose of the Phase 2 portion of this study is to continue testing safety of the study drug and to test if the study drug can prevent complications that frequently happen during transplantation, which include graft versus host disease (GvHD) and infections, specifically infection by an important virus called cytomegalovirus (CMV). GVHD happens when the transplanted donor blood cells attack the transplant patient’s body. CMV is a virus that is present in many people’s bodies without causing illness, but may cause illness in patients who undergo a stem cell transplant.
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) including T lymphoblastic lymphoma, Myelodysplastic Syndrome (MDS), or Chronic Myelogenous Leukemia (CML)
You may eligible if you:
-Have AML, ALL, MDS, or CML
-Are scheduled to undergo a hematopoietic stem cell transplant (HSCT) as treatment for your blood cancer, and
-Are atleast 18 years of age.
18 - 100
Healthy Volunteers Needed
Duration of Participation
Study participation will take approximately 26 months.
Clinical Trials Information Line
Fate Therapeutics, Inc.