Full Title
A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 Cell Infusion in Subjects with Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)Purpose
Graft-versus-host disease (GVHD) is a serious condition that can happen after a stem cell transplant from a donor. The donated cells see the healthy tissues in the recipient’s body as foreign and attack them. TRX103 is a new drug designed to reduce the risk of GVHD.
Researchers want to find the best dose of TRX103 for people receiving a stem cell transplant. The people in this study are having stem cell transplantation as a treatment for a blood cancer such as:
- Acute lymphocytic leukemia
- Acute myeloid leukemia
- Myelodysplastic syndrome
- Chronic myelomonocytic leukemia
TRX103 is a cellular therapy made from white blood cells (T cells) from the blood of three healthy unrelated donors. T cells are immune system cells that protect the body from infections, cancer, and other possible harms. TRX103 is given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Be scheduled to receive a stem cell transplant from a donor as treatment for blood cancer.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Miguel-Angel Perales’ office at 646-608-3757.