A Phase I Study of FT538 in People with Recurrent or Persistent Advanced Acute Myelogenous Leukemia or Multiple Myeloma

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Full Title

A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

Purpose

The purpose of this study is to assess the safety of an investigational cellular immunotherapy called FT538 in patients with advanced acute myelogenous leukemia (AML) or multiple myeloma that came back or continued to grow despite prior treatment. FT538 is made of white blood cells called natural killer (NK) cells that have been collected from a healthy donor and modified in a laboratory to detect and destroy cancer cells.

In this study, FT538 will be given alone in patients with AML and in some patients with multiple myeloma, and in combination with daratumumab or elotuzumab in other patients with multiple myeloma. FT538 treatments 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 advanced AML or multiple myeloma that came back or continued to grow despite prior treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 and to inquire about eligibility for this study, please contact Dr. Sham Mailankody at 646-608-3712.

Protocol

21-218

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators