Disease: Non-Hodgkin Lymphoma, NHL, (NCT04649112)

Disease info:

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in a type of white blood cells called lymphocytes, which are part of the body’s immune system. NHL is a term that is used for many different types of lymphoma that all share some of the same characteristics. NHL usually starts in lymph nodes or other lymph tissue, but it can sometimes affect the skin. 

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). B cell lymphoma may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms.

 

Frequency:
Non-hodgkin lymphoma (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. About 77,240 people (42,380 males and 34,860 females) will be diagnosed with NHL each year. This includes both adults and children.
Official title:
A Phase 1 Study of PBCAR19B in Participants with CD19-Expressing Malignancies
Who:

Study Chair: Monika Vainorius, MD  Precision BioSciences, Inc.

Partners:
Locations:

United States, California

United States, New York

Study start:
Jun. 16, 2021
Enrollment:
24 participants
Gene editing method:
Meganucleases
Type of edit:
Gene knock-out and gene knock-in
Gene:
T-cell Receptor Alpha Constant- TRAC, CD19 molecule
Delivery method:
- Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a Phase 1, non-randomised, open-label, single-dose, dose-escalation and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies. In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-hodgkin Lymphoma (NHL).

Intervention: Genetic: PBCAR19B

Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused

PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by preventing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the stealth vector carries a short hairpin RNA (shRNA) that suppresses expression of beta-2 microglobulin (B2M), a component of Class 1 major histocompatibility complex (MHC) molecules found on the cell surface. Reducing or knocking down Class 1 expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The stealth vector also carries a HLA-E gene intended to prevent rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface.

Last updated: Jul. 4, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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