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:
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 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

Partners:

Foresight Diagnostics, Inc.
 

Locations:

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

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

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

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

United States, Texas
Texas Oncology - Longview Cancer Center, Longview, Texas, United States, 75601

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

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
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: Jul. 24, 2024
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