Tests iNK cell therapy in adults with relapsed or refractory acute myeloid leukemia
Tests iNK cells, made from stem cells, in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with acute myeloid leukemia that came back or did not respond to treatment. They will receive iNK cell therapy.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Acute myeloid leukemia (AML) that has relapsed or did not respond to treatment (refractory), including secondary or treatment-related AML. Some people in first or second remission can also join.
- Earlier treatment
- Relapsed AML: relapse after at least 1 complete remission, including after a stem cell transplant (at least 2 months after the transplant). Refractory AML: no remission after 2 or more cycles of induction therapy. Secondary or treatment-related AML: at least 1 earlier treatment line for AML. People with earlier NK cell or CIK cell therapy cannot join.
Main reasons for not taking part
- Active infection, or heart, liver or kidney function problems
- Leukemia in the central nervous system
- Serious heart or blood vessel disease, such as heart failure or a heart attack in the last 6 months
- Another cancer now or before (with a few exceptions), or positive for hepatitis B surface antigen
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06702098, who can take part
Where in China
- Guangzhou Ruixin Biotechnology Co., LtdGuangzhou, ChinaContact: Luo Yun Luo, Medical Department ManagerNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Guangzhou Ruixin Biotechnological Co., LTD
- Trial code
- NCT06702098
- Record updated
- 22 November 2024
- Original description
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.Read full original descriptionShow less
Single-center and Single-arm Clinical Study of INK Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.
Inclusion: Patients must satisfy the following criteria to be enrolled in the study; Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF); Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted; Patient has eligible disease status:; 3.1 Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response Criteria (Dohner, 2017); 3.2 R/R diagnosis based on confirmed diagnosis with local pathology report following any reinduction/ salvage therapy ELN guidelines; 3.2.1 Relapsed AML are defined as having relapsed after achieving ≥ 1 CR, including relapse after allogeneic stem cell transplantation (≥ 2 months after transplant); 3.2.2 Refractory AML, defined as not achieving CR, CRi, or MLFS after 2 or more cycles of induction therapy (primary refractory) or not achieving CR after treatment for relapsed AML; 3.2.3 Secondary AML (MDS transformation): Secondary AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML; 3.2.4 Treatment-related AML: Treatment-related AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML; No active infection; No heart , liver and kidney functioninsufficiency; No central nervous system leukemia.
Exclusion: Subject meets one of the following criteria. 1.1History of CAR-T treatment with third degree CRS. 1.2 History of NK cell and CIK cell immunotherapy; Previous or present concomitant other malignancies (except for basal cell carcinoma of the skin, non-melanoma and non-melanoma, carcinoma in situ of the breast/cervix that have been effectively controlled, and other malignancies that have been effectively controlled without treatment in the past five years); Uncontrollable systemic disease(e.g. uncontrolled hypertension, diabetes, etc); history of severe neurological or psychiatric illness; Positive for hepatitis B surface antigen; Serious cardiovascular and cerebrovascular diseases. 2.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms; 2.2 Complete left bundle branch block, second- or third-degree atrioventricular block; 2.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 2.4 New York Heart Association (NYHA) class II or above congestive heart failure; 2.5 Left ventricular ejection fraction (LVEF) <50% in color Doppler echocardiography; 2.6 History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment; Pregnant women, lactating females, patients who refuse to use effective contraception during the study; Patients who are judged by the investigator to be unsuitable for participating in this study.