Acute myeloid leukemia
Conditions
Interventions
Single arm:Single, intravenous infusion of CAR-T cells
Sponsors
The First Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient or his/her guardian voluntarily signed the informed consent and was expected to complete the follow-up examination and treatment of the study procedure; 2. Aged 2 - 70 years, no gender limitation; 3. It meets the diagnosis of AML classified by WHO in 2016, and meets the diagnosis criteria of relapse and refractory in The Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory AML (2017 Edition), and is not suitable for clinically related treatment or registered clinical trials at present: (1) Diagnostic criteria for recurrent AML: recurrence of leukemia cells in peripheral blood or primitive cells in bone marrow > 0.050 after complete remission (except bone marrow regeneration after consolidation chemotherapy and other reasons) or extramedullary infiltration of leukemia cells. (2) Diagnostic criteria for refractory AML: initial patients who failed two courses of treatment with standard regimen; Relapse within 12 months after consolidation and intensification therapy; Patients who relapsed after 12 months but failed to respond to conventional chemotherapy; 2 or multiple recurrences; Persistent extramedullary leukemia; 4. AML Blast confirmed positive CLL1/CD33/ADGRE2 expression; 5. The patient has recovered from the toxicity of previous treatment, that is, CTCAE toxicity grade 3 months; 7. Having appropriate organ functions: (1) Aspartate aminotransferase (AST) = 60 mL/min; (5) Hemoglobin >= 60 g/L or maintain this level after blood transfusion; (6) Indoor oxygen saturation >= 92%; (7) Left ventricular ejection fraction (LVEF) >= 45%; 8. Female subjects must also meet the following criteria to be considered for inclusion: (1) Infertility, defined as: Previous hysterectomy or bilateral oophorectomy, or had bilateral tubal ligation, or menopause (complete menopause >= 1 year); (2) Fertile, has a negative serum pregnancy test at the time of screening, and has agreed to use medically approved contraceptive methods (such as intrauterine devices, contraceptives or condoms) before and during the study, up to 1 year after the last study use; 9. Sexually active men must agree to use barrier contraception or complete abstinence.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia was diagnosed; 2. Symptoms of active central nervous system leukemia; 3. Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive; Hepatitis C virus (HCV) antibody positive; Persons with positive antibodies to human immunodeficiency virus (HIV); Cytomegalovirus (CMV) DNA test results >= 500 copies/mL; Syphilis antibody positive; 4. People with a history of severe allergies [A history of severe allergies is defined as a secondary or higher allergic reaction with any of the following clinical manifestations: Airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmias, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest] or are known to be allergic to any drug active ingredient, excipients or products of rat origin or xenoproteins included in the test (including the eluent protocol); 5. Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, and refractory hypertension (refractory hypertension is defined as: On the basis of improving their lifestyle, they have been treated with a reasonable and tolerable sufficient amount of >= 3 kinds of antihypertensive drugs (including diuretics) > their blood pressure has not reached the standard in 1 month or their blood pressure can be effectively controlled by taking >= 4 kinds of antihypertensive drugs); 6. Those who have received or are preparing for organ transplantation (except hematopoietic stem cell transplantation); 7. Acute and chronic graft-versus-host disease (GVHD) or those taking immunosuppressants; 8. Screening patients who had received hematopoietic stem cell transplantation within the previous 3 months; 9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)); 10. Patients with tumor emergency symptoms (such as spinal cord compression, intestinal obstruction, leukocyte stasis, tumor lysis syndrome, etc.) before screening or infusion and requiring emergency treatment; 11. Presence of uncontrollable bacterial, fungal, viral or other infections requiring antibiotic treatment; 12. Those who had undergone major surgical operations (except diagnostic surgery and biopsy) within 4 weeks prior to cleansing or planned major surgical operations during the study period, or whose surgical wounds had not completely healed before enrollment; 13. Persons with serious mental illness; 14. Those who received live (attenuated) virus vaccine within 4 weeks prior to screening; 15. Alcoholics or those with a history of substance abuse; 16. Patients who, in the judgment of the investigator and/or clinical criteria, have contraindications to any study procedure or have other medical conditions that may place them at unacceptable risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Pharmacokinetic (PK) and pharmacodynamic (PD) evaluation;Efficacy evaluation index; | — |
Countries
China
Contacts
Public ContactHuang He
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed