Clinical Trial

Disease: Relapsed or Refractory B-cell Malignancies, (NCT03298828)

Disease info:

B-cell malignancies are cancers that arise from abnormalities in B cells, and include B-cell lymphomas and leukaemias. While leukaemias typically originate in the bone marrow and spread through the bloodstream, lymphomas usually originate in the lymph nodes or the spleen and spread through the lymphatic system.

There are more than 70 known types of B-cell lymphoma, and these make up approximately 85 % of all cases of non-Hodgkin lymphomas in the United States. NHL is one of the most common cancers in the United States, accounting for about 4% of all cancers. B-cell lymphomas may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. Other common types of B-cell lymphoma include:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma
  • Chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL)
  • Mantle cell lymphoma (MCL)
  • Marginal zone lymphomas
  • Burkitt lymphoma

In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. B-ALL is the most common type of ALL. Note that B-ALL is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

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.


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. ALL accounts for less than 1% of all cancers in the U.S., with 6,540 new cases estimated in the U.S. in 2023.
Official title:
CD19 Chimeric Antigen Receptor (CAR) and PD-1 Knockout Engineered T Cells for CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma


Name: Xiaoyun Shang, Dr.

Phone: +8618580607020



Third Military Medical University

Study start:
Oct. 1, 2017
30 participants
Gene editing method:
Type of edit:
Gene knock out
Programmed Cell Death 1 (PD-1)
Delivery method:
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown


The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells that are genetically modified to express a CD19-targting chimeric antigen receptor (CAR), and PD-1 knockout-engineered T cells in patients with relapsed or refractory B cell non-Hodgkin lymphoma lymphoma and leukaemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis to yield cells for generation of the CD19 CAR T-cells. Patients will receive the CD19 CAR and PD-1 knockout-engineered T-cells following lymphodepleting chemotherapy.

Last updated: Apr. 20, 2024
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