Clinical Trial

Disease: Leukemia Lymphocytic Acute in Relapse, Leukemia Lymphocytic Acute (All) Refractory Lymphoma, B-Cell, CD19 Positive, ALL, (NCT04037566)

Disease info:

Leukemia is cancer of the white blood cells. White blood cells help your body fight infection. Your blood cells form in your bone marrow. In leukemia, the bone marrow produces abnormal white blood cells. These cells crowd out the healthy blood cells, making it hard for blood to do its work.

Leukemia can develop quickly or slowly. Chronic leukemia grows slowly. In acute leukemia, the cells are very abnormal and their number increases rapidly. Adults can get either type;

There are different types of leukemia, including: 
Acute lymphocytic leukemia
Acute myeloid leukemia
Chronic lymphocytic leukemia
Chronic myeloid leukemia

Frequency:
Approximately 1.6 percent of men and women will be diagnosed with leukemia at some point during their lifetime, based on 2014-2016 data. Prevalence of this cancer: In 2016, there were an estimated 414,773 people living with leukemia in the United States.
Official title:
A Safety Study of Autologous T Cells Engineered to Target CD19 and CRISPR Gene Edited to Eliminate Endogenous HPK1 (XYF19 CAR-T Cells) for Relapsed or Refractory Haematopoietic Malignancies.
Who:

Principal Investigator: Guangxun GAO, Dr., Xijing Hospital
 

Sponsor:

Xijing Hospital, The Fourth Military Medical University

Partners:

Xi'An Yufan Biotechnology Co.,Ltd

Locations:

China, Shannxi

Study start:
Aug. 1, 2019
Enrollment:
40 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
CD19 molecule , HPK1 hematopoietic progenitor kinase 1 (also known as MAP4K1)
Delivery method:
Lentivirus (LV) and electroporation - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04037566
Safety updates:

No information 

Other links:

LinkLeukemia disease informationLinkLeukemia frequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a first-in-human trial proposed to test CD19-specific CAR-T cells with edited endogenous HPK1 (XYF19 CAR-T cells) in patients with relapsed or refractory CD19+ leukemia or lymphoma. This is an investigational study designed as a single-center, open-label and single-arm clinical trial. Autologous T cells engineered to specify CD19 transduced with a lentiviral vector and electroporated with CRISPR guide RNA to disrupt expression of endogenous HPK1 administered by IV injection.

Last updated: Apr. 10, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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