Disease: Relapsed or Refractory B-cell Malignancies, Non-Hodgkin lymphoma, NHL, (NCT04213469)

Disease info:

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in 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. 

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterized by abnormalities of the "B-cells" (a type of white blood cell that makes antibodies to help fight infection). The condition may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms.

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 Safety and Efficacy Evaluation of Quikin CD19-CART in Patients With Relapse/Refractory B-cell Lymphoma
Who:

Principal Investigator: He Huang, Prof.  First Affliated Hospital, Zhejiang University

Locations:

China, Zhejiang

Study start:
Mar. 13, 2020
Enrollment:
20 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out and gene knock-in
Gene:
Programmed Cell Death 1 (PD-1) , anti-CD19 CAR
Delivery method:
Electroporation - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This study aims to evaluate the safety and efficacy of the treatment with Quikin CD19-CART. Quikin CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, participants will be followed up to 15 years.

Initially, patients undergo leukapheresis and the removed cells are engineered with Quikin CD19- CART. Moving on, patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine 4-6 days before CART infusion. A dose of Quikin CD19-CART will be infused on day 0.

Last updated: Jul. 3, 2021
Source: National Medical Product Administration (NMPA)
english.nmpa.gov.cn
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