Disease: Non-Hodgkin Lymphoma, Relapsed-Refractory Large B Cell or Follicular Lymphoma, NHL, (NCT03939026)

Disease info:

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. 

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterized 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

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. This includes both adults and children.
Official title:
A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Who:

No information

Partners:
Locations:

United States, Arizona

United States, California

United States, Colorado

United States, Florida

United States, Texas

Study start:
May. 1, 2019
Enrollment:
54 participants
Gene editing method:
TALENs
Gene:
TCRα knockout. CD52 knockout.
Delivery method:
Electroporation of TALEN gene editing tools. Lentiviral transduction of CAR-T. - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

ALLO-501 is an investigational off-the-shelf CAR-T therapy using T-cells harvested from healthy donors.

These cells are isolated in a manufacturing facility, engineered to express synthetic T cell receptors, CARs (chimeric antigen receptors) to recognize and destroy cancer cells, and modified via gene editing to limit autoimmune response when given to a patient.

The harvested T-cells are edited using TALENs (Cellectis' technology) to knockout two genes.

T cell receptor gene is knocked out to minimize risk of GvHD​ (Graft versus Host Disease).

The CD52 gene is knocked out to render the CAR T product resistant to anti-CD52 antibody treatment. ALLO-647, anti-CD52 monoclonal antibody, is designed to suppress the host immune system and allow the AlloCAR-T TM therapy to stay engrafted in order to achieve full therapeutic impact.

ALLO-501 recognize CD19, a cell-surface protein expressed on B-cells, including cancerous B-cells.

Last updated: Aug. 15, 2020
close
Search CRISPR Medicine