Clinical Trial

Disease: Relapsed or Refractory Acute Myeloid Leukemia, AML, (NCT06541444)

Disease info:

Leukaemia is cancer of the white blood cells which are responsible for fighting infection. In leukaemia, the bone marrow produces abnormal levels of white blood cells. Acute myeloid leukaemia (AML) starts in the bone marrow but often quickly spreads into the bloodstream. AML sometimes spreads to other parts of the body such as the lymph nodes, liver, central nervous system and testicles. 

Commonly, AML develops from cells other than lymphocytes that would normally develop into white blood cells. The World Health Organization (WHO) divides AML into several subtypes based off genetic association. AML is also known as acute myelocytic leukaemia, acute myelogenous leukaemia, acute granulocytic leukaemia, and acute non-lymphocytic 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.

 

Frequency:
An estimated 22,010 people will be diagnosed with AML in the United States in 2025.
Official title:
An Open, Single Center Exploratory Study to Evaluate Safety and Efficacy of NK520 for Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who:

Contact 

Name: Jun Yan

Phone: 13817651474

Email: yanjun@basetherapeutics.com

Sponsor:

Base Therapeutics (Shanghai) Co., Ltd.

Partners:

Shanghai Pudong Hospital
 

Locations:

Shanghai Municipality, China

Shanghai Pudong Hospital, Shanghai, Shanghai Municipality, China, 201202

Study start:
Jul. 1, 2024
Enrollment:
9
Gene editing method:
AccuBase® base editor
Type of edit:
Gene knockout and gene knock in
Gene:
Knockout of PD-1 and knock in of CD16
Delivery method:
- Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This open label, single-arm study aims to evaluate the efficacy and safety of allogenic NK cells in subjects with relapsed/refractory acute myeloid leukemia. Allogenic NK cells will be infused once a week. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable dose(MTD). To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Last updated: Sep. 22, 2025
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