Clinical Trial

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

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

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in 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. Non-Hodgkin lymphoma is one of the most common cancers in the United States, accounting for about 4% of all cancers. 

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:
B-cell NHL is the most common type of non-Hodgkin lymphoma. 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:
A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
Who:

Contact

Clinical Precision BioSciences, Inc.

Phone: 919-314-5512

Email: clinical@precisionbiosciences.com

Sponsor:

Precision BioSciences Inc.

Partners:

None 

Locations:

United States, California

City of Hope, Duarte, California, United States, 91010

 

United States, Massachusetts

Tufts Medical Center, Boston, Massachusetts, United States, 02111

 

United States, New York

Columbia University, New York, New York, United States, 10032

 

United States, Pennsylvania

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

 

United States, Rhode Island

Lifespan Cancer Institute at Rhode Island Hospital, Providence, Rhode Island, United States, 02903

 

United States, Arizona

Banner MDA, Gilbert, Arizona, United States, 85234

 

United States, Florida

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Study start:
Jun. 16, 2021
Enrollment:
13 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
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04649112
Safety updates:

(08-06-2022) Precision BioSciences Provides Update on Allogeneic CAR T Programs and Path Forward with Its Lead PBCAR0191 Candidate for CAR T Relapsed Patient Population

(11-12-2021) Precision BioSciences Reports Clinical Program Updates for Its Allogeneic CAR T Pipeline

(01-07-2021) Precision BioSciences Doses First Patient in Phase 1 Allogeneic CAR T Clinical Trial of PBCAR19B Immune Evading Stealth Cell for Relapsed/Refractory Non-Hodgkin Lymphoma

(19-01-2021) Precision BioSciences Announces FDA Accepts IND for PBCAR19B, a Next-Generation, Stealth Cell, CD19 Allogeneic CAR T Candidate for Non-Hodgkin Lymphoma

Other links:

LinkNon-Hodgkin’s Lymphoma- B cell malignancies InformationLinkNon-Hodgkin’s Lymphoma FrequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkPrecision BioSciences Receives Notice of Allowance for U.S. Patent Application Covering PBCAR19B, a Stealth Cell, CD19 Allogeneic CAR T Candidate for Non-Hodgkin LymphomaLinkClinical Trial Update - Meganuclease-Edited CAR T-Cell TherapiesLinkPrecision BioSciences Doses First Patient in Phase 1 Allogeneic CAR T Clinical Trial of PBCAR19B Immune Evading Stealth Cell for Relapsed/Refractory Non-Hodgkin Lymphoma

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

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: Aug. 31, 2024
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