Clinical Trial

Disease: Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study (NCT05822427)

Disease info:

This is a Long-Term Follow-Up (LTFU) observational study designed for individuals who recieved an allogeneic chimeric antigen receptor T-cell product (PBCAR) in a Precision BioSciences, Inc., clinical study. These include patients with diffuse large B-cell lymphoma (DLBCL), and other lymphomas.

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.

Diffuse large B-cell lymphoma (DLBCL), a form of non-Hodgkin lymphoma, is the most common blood cancer. Lymphomas occur when cells of the immune system, known as B lymphocytes, grow and multiply uncontrollably. DLBCL occurs mostly in adults and is a fast-growing (aggressive) lymphoma. It can start in the lymph nodes or outside of the lymphatic system in the gastrointestinal tract, testes, thyroid, skin, breast, bone, or brain. Often, the first sign of DLBCL is a painless rapid swelling in the neck, armpit, abdomen, or groin caused by enlarged lymph nodes. For some people, the swelling may be painful. Other symptoms include night sweats, unexplained fevers, and weight loss.

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's 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. 

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

Frequency:
DLBCL makes up approximately 40% of NHL cancers. NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023.
Official title:
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in a Precision BioSciences, Inc., Clinical Study
Who:

Contact

Phone: 919-314-5512

Email: clinical@precisionbiosciences.com

Partners:
Locations:

United States, California

Culver City, California, United States, 90230

Study start:
Aug. 25, 2020
Enrollment:
75 participants
Gene editing method:
ARCUS
Type of edit:
Gene knock-down, gene knock-in
Gene:
Insert CD19 CAR transgene, knock-down beta-2 microglobulin, and insert HLA-E transgene
Delivery method:
Both non-viral and viral - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

The goal of this study is to collect information on the long-term safety of study participants who received Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in a Precision BioSciences, Inc. (PBI) Clinical Study. The main questions it aims to answer are:

-What were the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?

Participants will visit a study center 3 times during the first year, and once per year after that for a physical exam and other assessments to check for CEI.

Last updated: Oct. 4, 2024
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