Clinical Trial

Disease: Multiple Myeloma, MM, (NCT05069935)

Disease info:

Multiple myeloma is a cancer that develops in the bone marrow, the spongy tissue found in the centre of most bones. Multiple myeloma is characterised by abnormalities in plasma cells, a type of white blood cell. In myeloma, these abnormal cells multiply uncontrollably, increasing from about one percent of cells in the bone marrow to the majority of bone marrow cells. The abnormal cells form tumours within the bone, causing bone pain and an increased risk of fractures.

Relapsed myeloma refers to when a patient had active treatment that their disease responded to, went off treatment and then the disease came back. 

Refractory myeloma is a disease that is progressing despite active treatment.


Multiple myeloma occurs in approximately 4 per 100,000 people per year; there are currently about 100,000 affected individuals in the United States.
Official title:
A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors


Name: Smriti Rai

Phone: 858-875-1800


Name: Karen Albers

Phone: 858-875-1800



United States, Arizona

Honor Health Research Institute, Scottsdale, Arizona, United States


United States, California

UCLA Division of Hematology-OncologyRecruitingLos Angeles, California, United States, 90404


United States, New Jersey

Hackensack University Medical Center - John Theurer Cancer Center, Hackensack, New Jersey, United States, 07601   


United States, North Carolina

Carolina BioOncology Institute, Huntersville, North Carolina, United States, 28078


United States, Texas

NEXT Oncology, San Antonio, Texas, United States, 78229

Study start:
Oct. 15, 2021
189 participants
Gene editing method:
Type of edit:
Gene knock-out
Delivery method:
Undisclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumours. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts. FT538 is an allogeneic gene-edited natural killer (NK)-cell immunotherapy.

Last updated: Apr. 20, 2024
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