Disease: Relapsed/Refractory Large B-Cell Lymphoma, LBCL, (NCT04416984)

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). 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. 

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 yearly. This includes both adults and children.
Official title:
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
Who:

No information

Partners:
Locations:

United States, California

United States, Colorado

United States, Florida

United States, Texas

United States, Kentucky

United States, Massachusetts

United States, New York

United States, Pennsylvania

United States, Wisconsin

Study start:
May. 21, 2020
Enrollment:
30 participants
Gene editing method:
TALENs
Type of edit:
Gene knock-out
Gene:
T Cell Receptor alpha locus TCRα, CD52 molecule
Delivery method:
Electroporation and Lentiviral - Ex-vivo
IndicatorIndicator
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-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

ALLO-501A is an anti-CD19 Allogeneic CAR T-cell therapy that, unlike autologous cell therapy, uses T cells from healthy donors. These cells are isolated in a manufacturing facility, engineered to express CARs to recognise and destroy cancer cells, and modified via gene editing to limit autoimmune responses when administered to a patient.

Last updated: Jul. 11, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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