A Phase I Study of AB-205 in Adults with Lymphoma Undergoing High-Dose Chemotherapy and Autologous Stem Cell Transplantation

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Full Title

A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation

Purpose

Using a patient’s own cells (special cells called “stem cells”) to help increase blood counts after high doses of chemotherapy is called autologous stem cell transplantation (ASCT). ASCT is a treatment approach used for some patients with lymphoma, but it can cause significant side effects. In this study, researchers are assessing the safety of the investigational drug AB-205 in patients undergoing high-dose chemotherapy and ASCT for lymphoma, to see if it can reduce the side effects of this treatment and help patients recover faster.

AB-205 is made in a laboratory using endothelial cells that come from healthy umbilical cord blood stem cells. Endothelial cells normally line the inside of blood vessels and are damaged along with surrounding tissues by chemotherapy. Researchers think that AB-205 may help prevent or lessen the severity and duration of side effects from high-dose chemotherapy by more quickly healing injured endothelial cells and surrounding tissues.

AB-205 is given intravenously (by vein) four hours after ASCT.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have Hodgkin or non-Hodgkin lymphoma and be candidates for high-dose chemotherapy and ASCT.
  • Patients who have already had ASCT may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Scordo at 212-639-6052.

Protocol

19-165

Phase

I

Investigator

Co-Investigators