Clinical Trial

Disease: Large B-cell lymphoma, LBCL, (NCT06500273)

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:
NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,350 people will be diagnosed with NHL in 2025.
Official title:
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
Who:

Contact

Phone: +1 415-604-5696

Email: clinicaltrials@allogene.com

Sponsor:

Allogene Therapeutics

Partners:

Foresight Diagnostics, Inc.
 

Locations:

United States, California

Alta Bates Summit Medical Center, Berkeley, California, United States, 94704

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

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States, 91817


United States, Colorado

Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80218
 

United States, Delaware 

Medical Oncology Hematology Consultants, Newark, Delaware, United States, 19713
 

United States, Florida 

Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States, 33176

Advent Health Cancer Institute, Orlando, Florida, United States, 32804

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

United States, Indiana 

Indiana Blood and Marrow Transplantation, Indianapolis, Indiana, United States, 46237
 

United States, Kansas

The University of Kansas Hospital, Kansas City, Kansas, United States, 66205
 

United States, Kentucky

University of Kentucky Medical Center, Lexington, Kentucky, United States, 40536

University of Louisville Health Brown Cancer Center, Louisville, Kentucky, United States, 40202

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

United States, Massachusetts 

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
 

United States, Missouri 

Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States, 63110


United States, New Jersey 

Astera Cancer Care, East Brunswick, New Jersey, United States, 08816

John Theurer Cancer Center, Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901


United States, New York 

Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York, United States, 10032
 

United States, Ohio 

Oncology Hematology Care - Kenwood, Cincinnati, Ohio, United States, 45236

University of Cincinnati Medical Center, Cincinnati, Ohio, United States, 45267

Cleveland Clinic, Cleveland, Ohio, United States, 44195
 

United States, Oregon 

Oncology Associates of Oregon, Eugene, Oregon, United States, 97401
 

United States, Texas 

Texas Oncology - Central South, Austin, Texas, United States, 78705

Texas Oncology - Dallas Fort Worth, Dallas, Texas, United States, 75246

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Texas Transplant Institute, San Antonio, Texas, United States, 78229

Texas Oncology - Tyler, Tyler, Texas, United States, 75702

 

United States, Virginia

University of Virginia, Charlottesville, Virginia, United States, 22903

Virginia Cancer Specialists, Fairfax, Virginia, United States, 22031

Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States, 23502
 

United States, Washington 

Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109
 

Study start:
Jun. 18, 2024
Enrollment:
250 participants
Gene editing method:
TALENs
Type of edit:
Gene disruption
Gene:
T cell receptor (TCR) gene, TRAC, & CD52
Delivery method:
Lentivirus and electroporation - Ex-vivo
Trial link:
https://clinicaltrials.gov/study/NCT06500273
Safety updates:

(20-06-2024) Allogene Therapeutics Initiates Pivotal Phase 2 Trial Investigating Cemacabtagene Ansegedleucel (cema-cel), an Allogeneic CAR T Product, as Part of First Line Treatment for Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse

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

Status: Active recruiting

Description

This is a randomized, open-label study in adult patients who have completed standard first line of therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.

The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.

Last updated: Feb. 25, 2025
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