A Phase I Study of FT596 Immunotherapy with or without Rituximab or Obinutuzumab in People with B-Cell Lymphoma and Chronic Lymphocytic Leukemia

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Full Title

A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination with Rituximab or Obinutuzumab in Subjects with Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia

Purpose

The purpose of this study is to determine the highest dose of the investigational immunotherapy FT596 that can be given safely alone and in combination with other anticancer medications in people with B-cell lymphoma or chronic lymphocytic leukemia (CLL) that has come back or continued to grow despite treatment.

FT596 is a type of cellular immunotherapy made up of natural killer cells (NK cells), a type of blood cell in the immune system, and they help attack cancer cells. The NK cells come from a healthy donor and are modified in the laboratory to detect and destroy patients’ cancer cells.

Patients in this study will receive FT596 alone or in combination with rituximab or obinutuzumab, which are standard treatments for these cancers. Before FT596, all patients will receive the chemotherapy drugs fludarabine and cyclophosphamide to prepare their bodies for the treatment. All of the medications used in this study are given intravenously (by vein).

Eligibility

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

  • Patients must have B-cell lymphoma that expresses the CD19 and CD20 proteins or CLL that came back or continued to grow despite treatment.
  • Patients should recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 646-608-3743.

Protocol

20-501

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators