Clinical Trial

Disease: B-Cell Malignancies, NHL, (NCT04629729)

Disease info:

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterised by abnormalities of the "B-cells" (a type of white blood cell that makes antibodies to help fight infection). The condition may spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms.

In 2016, there were an estimated 694,704 people living with non-Hodgkin lymphoma in the United States.
Official title:
A Phase I Study of FT819 in Subjects With B-cell Malignancies

Contact: Fate Trial Disclosure

Phone: 866-875-1800



United States, Alabama

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294


United States, California

UCLA Ronald Reagan Medical Center, Los Angeles, California, United States, 90095

Stanford Cancer Institute, Palo Alto, California, United States, 94304


United States, Iowa

University of Iowa, Iowa City, Iowa, United States, 52242


United States, Kansas

The University of Kansas Medical Center, Westwood, Kansas, United States, 66205


United States, Kentucky

Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, United States, 40207


United States, Nebraska

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198


United States, New Jersey

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601


United States, New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021


United States, Oregon

Oregon Health & Sciences University, Portland, Oregon, United States, 97239


United States, Texas

MD Anderson Cancer Center, Houston, Texas, United States, 77030


United States, Wisconsin

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53705

Study start:
Jul. 6, 2021
396 participants
Gene editing method:
Type of edit:
Gene knock-out, gene knock-in
anti-CD19 molecule , T Cell Receptor Alpha Constant (TRAC)
Delivery method:
Electroporation and viral (AAV) - Ex-vivo
FT819 is an off-the-shelf CAR T-cell cancer immunotherapy derived from a clonal engineered master iPSC line with a novel 1XX CAR targeting CD19 inserted into the T cell receptor alpha constant (TRAC) locus and edited for elimination of T cell receptor (TCR) expression.
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is a Phase I dose-finding study of FT819, either as monotherapy or in combination with IL-2 in subjects with relapsed/refractory B-cell lymphoma, chronic lymphocytic leukaemia and precursor B-cell acute lymphoblastic leukaemia (B-ALL). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

FT819 is developed using precise genetic engineering and multiple targeting events at the single cell level, and it is derived from a clonally-derived master cell bank (MCB) that serves as the starting material to support consistent and reproducible clinical manufacturing. The engineered features of FT819 include the targeted integration of a novel CD19 1XX-CAR into the T cell receptor α constant (TRAC) locus to provide antigen specificity, enhanced efficacy and temporally-regulated CAR expression driven by an endogenous (TCR) promoter. Such features are designed to also eliminate the possibility of graft versus host disease (GvHD) by nullifying the TCR.

Last updated: Jun. 5, 2023
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