Acute myeloid leukemia
Conditions
Interventions
experimental group:Dual CD33-CLL1 CAR-NK Cells
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18 to 70 years; 2.ECOG performance status score 0 or 1.Life expectancy >= 12 weeks from the time of enrollment; 3.Disease status at the time of enrollment: (1)Patients with AML (except M3) who have not achieved complete remission after standard chemotherapy regimens; (2)Not suitable or unconditional for allogeneic hematopoietic stem cell transplantation. 4.CD33 and/or CLL1 expression must be detected on malignant cells by immunohistochemistry or flow cytometry; 5.Adequate main organ function as assessed by the following laboratory requirements: (1)Creatinine = 90%, (3)Total bilirubin =80g/L. 6.Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immune suppressive drugs or corticosteroid treatment) within 2 weeks of screening; 7.Adequate venous access for apheresis, and no other contraindications for leukapheresis; 8.Women of child-bearing age must have evidence of negative pregnancy test.Subjects of reproductive potential must agree to use acceptable birth control methods within 36 months after treatment, as described in protocol; 9.After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk; 10.All participants must have the ability to understand and willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded; 2.Have been diagnosed with or treated other malignant tumors other than AML within 5 years before screening, except for the following conditions: participants with adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer; or received radical treatment Local prostate cancer, ductal carcinoma in situ; 3.There are serious systemic diseases: New York Heart Association (NYHA) stage iii or iv congestive heart failure; cerebrovascular accident or myocardial infarction or hemodynamic instability caused by arrhythmia within 6 months before signing the informed consent; impaired cardiac function (LVEF= 5/µL white blood cells (WBCs) in cerebral spinal fluid (CSF) and cytospin positive for blasts [in the absence of a traumatic lumbar puncture] and/or clinical signs of CNS leukemia such as a cranial nerve palsy from active disease). Subjects with adequately treated CNS leukemia are eligible; 7.Human immunodeficiency virus (HIV) seropositivity; hepatitis B surface antigen is positive or HBV DNA is higher than the detection limit of the analysis method; hepatitis C antibody is positive or HCV RNA is higher than the detection limit of the analysis method; syphilis antibody and syphilis rapid plasma reagin are positive; CMV DNA is positive; 8.Patients who suffer from allergies for any cytokines or antibodies; 9.Contraindications for fludarabine or cyclophosphamide treatment; 10.Receiving corticosteroids at >20 mg daily prednisone dose or equivalent; 11.Drug abuse and addiction.History of mental disorders; 12.Other patients that researchers considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;efficacy;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactCao Jiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed