Clinical Trial

Disease: Hematologic Malignancies, (NCT04023071)

Disease info:

Haematological cancers most often begin in the bone marrow where blood is produced. Stem cells in the bone marrow develop into white blood cells, red blood cells, or platelets. Blood cancers occur when uncontrolled growth of abnormal blood cells overtakes the development of normal blood cells and interferes with the regular functions of these cells. Blood cancers fall into three categories: leukaemia, lymphoma, and myeloma.

Leukaemias are blood cell cancers; some leukaemias are fast growing, while others develop slowly. Lymphoma occurs when lymphocytes (infection-fighting white blood cells) develop abnormally and become cancerous. These multiply and aggregate in lymph nodes and other tissues. Among common lymphomas are Hodgkin lymphoma, non-Hodgkin Lymphoma, AIDS-related lymphoma, and primary central nervous system (CNS) lymphoma. Myeloma is a cancer that occurs in plasma cells. Normal plasma cells produce antibodies that fight disease and infection. However, when abnormal plasma cells develop, they interfere with  antibody production and lead to reduced immunity.

Between 2006 and 2016, the global leukaemia incidence increased by 26%—from 370,482 to 466,802 cases. Non-Hodgkin lymphoma increased by 45%, from 319,078 to 461,164 cases.
Official title:
A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma

United States, Arizona 
Mayo Clinic, Phoenix, Arizona, United States, 85054

United States, California 
UC San Diego, San Diego, California, United States, 92037

United States, Colorado 
University of Colorado, Denver, Denver, Colorado, United States, 80045

United States, Minnesota 
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States, 55455

United States, Texas 
UT Southwestern, Dallas, Texas, United States, 75390
MD Anderson Cancer Center, Houston, Texas, United States, 77030

United States, Washington 
Swedish Cancer Institute, Seattle, Washington, United States, 98104

Study start:
Oct. 4, 2019
72 participants
Gene editing method:
Type of edit:
Gene enhancement
Delivery method:
- Ex-vivo
The study was terminated by the Sponsor.
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Terminated


This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.

Last updated: Jan. 16, 2024
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