Clinical Trial

Disease: Diffuse Large B-cell Lymphoma, DLBCL, (NCT04026100)

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 Phase I Clinical Trial of CTA101 UCART Cells Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma


Name: Jianyong Li, Ph.D


Phone: 025-83718836



China, Jiangsu

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China, 210000

Study start:
Dec. 1, 2019
9 participants
Gene editing method:
Type of edit:
Gene knock out
T Cell Receptor Alpha Constant (TRAC) region, CD52 gene
Delivery method:
Electroporation and Lentivirus (LV) - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown


The study aims to evaluate the safety and efficacy of CTA101 in relapsed or refractory diffuse large B-cell lymphoma patients. CTA101 is a CRISPR-Cas9 engineered, off-the-shelf, CD19/CD22 dual-targeted CAR T cell product. Prior to CTA101 infusion, study participants will receive pre-conditioning chemotherapy regimen consisting of cyclophosphamide, fludarabine and alemtuzumab. After chemotherapy, study participants will receive one infusion of Universal CD19-directed CAR-T cells in escalating doses.

Last updated: Dec. 28, 2023
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