Clinical Trial

Disease: Multiple Myeloma, Relapsed/Refractory Acute Myeloid Leukaemia, AML, (NCT04614636)

Disease info:

Leukaemia is cancer of the white blood cells. White blood cells help your body to fight infection. Your blood cells form in your bone marrow. In leukaemia, however, the bone marrow produces abnormal white blood cells. These cells crowd out the healthy blood cells, making it hard for blood to do its work. In acute myeloid leukaemia (AML), there are too many of a specific type of white blood cell called a myeloblast.

AML is the most common type of acute leukaemia in adults. This type of cancer usually gets worse quickly if it is not treated. 

The estimated number of new cases of acute myeloid leukaemia is 4.3 per 100,000 men and women per year. The estimated number of deaths is 2.8 per 100,000 men and women per year. These rates are age-adjusted and based on 2012-2016 cases and deaths.
Official title:
A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukaemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

Study Director: John Byon, MD, Fate Therapeutics, Inc




United States, Minnesota

United States, Missouri

United States, New York 

United States, Tennessee

United States, Texas

United States, Colorado

United States, New Jersey

Study start:
Nov. 4, 2020
105 participants
Gene editing method:
Type of edit:
Gene knock-out
Cluster of differentiation 38 (CD38)
Delivery method:
- Ex-vivo
hnCD16 to universally engage monoclonal Antibodies (mAbs) IL15-RF to enable natural killer (NK) cell persistence without the need for exogenous cytokine support CD38 knock-out for resistance to mAb-mediation
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


The first-in-human, multi-center, dose-escalation Phase 1 clinical trial of FT538 is designed to determine the maximum tolerated dose (MTD) of three once-weekly doses of FT538 in up to 105 adult patients across four dose cohorts (100M cells per dose; 300M cells per dose; 900M cells per dose; and 1.5B cells per dose). The study will assess two treatment regimens: Regimen A as a monotherapy in patients with relapsed / refractory AML; and Regimen B in combination with daratumumab, an FDA-approved anti-CD38 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy.

FT538 is an off-the-shelf adoptive NK cell immunotherapy product candidate designed for enhanced cellular persistence and ADCC while avoiding anti-CD38 mAb-induced fratricide. It is derived from induced pluripotent stem cells (iPSC) that are engineered to lack CD38 expression. Fate Therapeutics has previously shown that this approach prevents daratumumab-induced fratricide among iPSC-derived NK cells, resulting in enhanced long-term daratumumab-mediated antibody-dependent cellular cytotoxicity (ADCC). FT538 is engineered to express an IL-15 receptor alpha fusion protein (IL-15RF; IL-15 tethered to IL-15 receptor α) to enhance persistence and a high-affinity non-cleavable CD16 (hnCD16, FcRγIII) to increase ADCC.

Last updated: Jul. 24, 2022
Source: US National Institutes of Health (NIH)
Search CRISPR Medicine