B-cell acute lymphoblastic leukaemia is an aggressive type of blood cancer that occurs because too many B-cell lymphoblasts (immature white blood cells) exist in the bone marrow and blood. It is the most common type of acute lymphoblastic leukemia (ALL). Note that B-cell ALL is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia.
Disease: B-cell Acute Lymphoblastic Leukemia, ALL, (NCT03298828)
Disease info:
Frequency:
The American Cancer Society’s estimates for acute lymphocytic leukaemia (ALL) in the United States for 2020 are: About 6,150 new cases of ALL (3,470 in males and 2,680 in females). About 1,520 deaths from ALL (860 in males and 660 in females).
Official title:
CD19 Chimeric Antigen Receptor (CAR) and PD-1 Knockout Engineered T Cells for CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Who:
Principal Investigator: Xiaoyun Shang, Dr. Third Military Medical University
Sponsor:
Third Military Medical University
Partners:
Locations:
No information
Study start:
Oct. 2, 2017
Enrollment:
30 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock out
Gene:
Programmed Cell Death 1 (PD-1)
Delivery method:
ex-vivo
Other links:
B-cell Acute Lymphoblastic Leukemia Disease InformationB-cell Acute Lymphoblastic Leukemia FrequencyThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimCAR T Cells for Solid Tumors: New Strategies for Finding, Infiltrating, and Surviving in the Tumor Microenvironment
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy
Status: Active not recruiting
Description
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. 8, 2022Source: US National Institutes of Health (NIH)
clinicaltrials.gov
clinicaltrials.gov
