Clinical Trial

Disease: 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:

Contact

Allogene Therapeutics Inc.

Phone: 415-604-5696

Email: clinicaltrials@allogene.com

Partners:
Locations:

United States, California

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

UCLA Medical Center, Los Angeles, California, United States, 90095

 

United States, Colorado

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218-1234

 

United States, Connecticut

Yale School of Medicine, New Haven, Connecticut, United States, 06510

 

United States, Florida

University of Miami, Miami, Florida, United States, 33136

Moffitt Cancer Center, Tampa, Florida, United States, 33612-9416

 

United States, Texas

St. David's South Austin Medical Center, Austin, Texas, United States, 78704 

MD Anderson Cancer Center - University of Texas, Houston, Texas, United States, 77030

 

United States, Kentucky

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

 

United States, New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

 

United States, Wisconsin

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

 

United States, Arizona

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

 

United States, Michigan

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

 

United States, Oregon 

Providence Portland Medical Center, Portland, Oregon, United States, 97213

 

United States, Tennessee

Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States, 37232

 

Study start:
May. 21, 2020
Enrollment:
160 participants
Gene editing method:
TALENs
Type of edit:
Gene knock-out
Gene:
T Cell Receptor alpha locus TCRα (TRAC), 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: Sep. 25, 2023
close
Search CRISPR Medicine