Disease: Relapsed or Refractory 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. 

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. This includes both adults and children.
Official title:
A Phase I Clinical Trial of CTA101 UCART Cells Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Locations:

China, Jiangsu

Study start:
Dec. 1, 2019
Enrollment:
9 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock out
Gene:
T Cell Receptor Alpha Constant (TRAC), CD52 molecule
Delivery method:
Electroporation and Lentivirus (LV) - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

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: Jul. 11, 2021
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