Clinical Trial

Disease: Relapsed or 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. 

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.

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:
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)


Allogene Therapeutics Inc.

Phone: 415-604-5696



United States, Arizona

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

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


United States, California

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

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

Stanford Cancer Institute, Palo Alto, California, United States, 94035


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

Advent Health, Orlando, Florida, United States, 06510

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


United States, Georgia

Northside Hospital - Atlanta, Atlanta, Georgia, United States, 30342

Augusta University, Augusta, Georgia, United States, 30912


United States, Illinois

Loyola University Medical Center, Maywood, Illinois, United States, 60153


United States, Kentucky

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


United States, Michigan

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


United States, New York

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


United States, Oregon 

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


United States, Pennsylvania

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States, 15212


United States, South Dakota 
Avera Medical, Sioux Falls, South Dakota, United States, 57117


United States, Tennessee

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


United States, Texas

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

Texas Oncology, Dallas, Texas, United States, 75251

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


United States, Wisconsin

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


Australia, Queensland 

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Monash Medical Centre, Clayton, Victoria, Australia, 3168

St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia, 3065

The Alfred Hospital, Melbourne, Victoria, Australia, 3004


Canada, Québec

CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus, Québec, Canada, G1J 1Z4


Canada, British Columbia

Vancouver General Hospital, Vancouver, British Columbia, Canada, V5Z 1M9


Canada, Nova Scotia 

QEII Health Sciences Centre-VG Site, Halifax, Nova Scotia, Canada, B3H 2Y9


Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi, Bologna, Italy, 40138

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan, Italy, 20132

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Torino, Italy, 10126



Hospital Universitari Vall d'Hebrón, Barcelona, Spain, 08035

Hospital Universitario Donostia, Donostia-San Sebastian, Spain, 20014

Hospital Universitario 12 de Octubre, Madrid, Spain, 28041

Hospital Universitario La Paz, Madrid, Spain, 28046

Complot Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca, Spain, 37007


Study start:
May. 21, 2020
160 participants
Gene editing method:
Type of edit:
Gene knock-out
T Cell Receptor alpha locus TCRα (TRAC), CD52 molecule
Delivery method:
Electroporation and Lentiviral - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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: Feb. 21, 2024
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