Disease: B Cell Malignancies, Precursor B-Cell Acute Lymphoblastic Leukemia, B Cell Lymphoma, NHL

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.

Frequency:
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
Who:

Study Director: Rebecca Elstrom, MD, Fate Therapeutics

Partners:

No

Locations:

United States, Kansas

United States, New York

United States, Texas

Study start:
Dec. 15, 2020
Enrollment:
297 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out, gene knock-in
Gene:
anti-CD19 molecule , T Cell Receptor Alpha Constant (TRAC)
Delivery method:
Electroporation and viral (AAV) - Ex-vivo
Note:
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.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active not recruiting

Description

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: Sep. 15, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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