Acute myeloid leukemia
Conditions
Interventions
Group 1 :CAR-T
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients or their legal guardians voluntarily sign the informed consent and are expected to complete the follow-up examination and treatment of the research procedures; 2. Age 1-18 years old, gender is not limited; 3. Relapsed and refractory acute myeloid leukemia (r/rAML) patients: AML patients (including secondary patients) diagnosed by pathology, histology and flow cytometry, relapsed during chemotherapy, or primary drug resistance, or complete hematological remission cannot be obtained after one course of chemotherapy for hematological recurrence after drug withdrawal (standards refer to NCCN, 2021.3); 4. Bone marrow CLL1 antigen expression is greater than 90%, or CLL1 expression is less than 90% and CD33 expression is greater than 90%; 5. ECOG physical status score 0-2 points; 6. The main tissues and organs of the patient are in good function: (1) Liver function: ALT/AST = 92%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%; 7. The peripheral superficial vein blood flow of the patient is smooth, which can meet the needs of intravenous infusion and mononuclear cell collection; 8. Female patients are not pregnant or breastfeeding; 9. Sexually active male patients must agree to take barrier contraceptive measures or complete abstinence.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with acute promyelocytic leukemia; 2. Patients had uncontrollable infectious diseases within 4 weeks before enrollment; 3. Patients with active hepatitis B/C virus, human immunodeficiency virus (HIV) infection, cytomegalovirus (CMV) DNA test positive, treponema pallidum (TP) test positive or HTLV test positive; 4. Known to have allergic reactions to any ingredients used in the treatment of this study; 5. Patients with other primary tumors other than acute myeloid leukemia diagnosed by pathology; 6. Suffering from severe autoimmune diseases or immunodeficiency diseases; 7. According to the investigator's judgment and/or clinical standards, patients who have contraindications to any research procedure or have other medical conditions that may expose them to unacceptable risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose limited toxicity, DLT;Maximal Tolerable Dose, MTD; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety index;overall response rate, ORR;duration of remission, DOR;Progression-free survival, PFS;overall survival; | — |
Countries
China
Contacts
Public ContactZhou Dunhua
Guangzhou Bio-gene Technology Co., Ltd
Outcome results
None listed