Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia

Korábbi kezelés

• 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).

Más betegség

• Uncontrollable systemic disease(e.g. uncontrolled hypertension, diabetes, etc).
• history of severe neurological or psychiatric illness.
• Positive for hepatitis B surface antigen.

Laborértékek

• 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.

Egyéb

• 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.

• 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.