Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological Malignancies
AML
About this trial
This is an interventional treatment trial for AML focused on measuring AML, CLL1 CAR T-cell therapy
Eligibility Criteria
Inclusion Criteria:
1. Patients is histologically diagnosed with CLL1-positive AML according to the NCCN Clinical Practice Guidelines in Oncology:Acute Myeloid Leukemia(Version 2.2021) 2. The diagnosis is consistent with r/r CLL1 + AML, and includes any of the following conditions:
- No CR was obtained after 2 courses of standard chemotherapy
- The first induction was CR, but the duration of CR was less than 12 months
- No CR was obtained after the first or multiple remedial treatment;
Relapse twice or more; 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
4. No active lung infection, inhaled air oxygen saturation ≥92% 5. The estimated survival time is more than 3 months 6. ECOG score was 0-2 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria:
- 1. Patients with history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with uncontrolled active infection; 5. Active hepatitis B or hepatitis C virus infection; 6. Previous application of gene therapy; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl; 9. Those who suffer from other uncontrolled diseases are not suitable to join the study; 10. HIV infection; 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Sites / Locations
- The first affiliated hospital of medical college of zhejiang universityRecruiting
- The First Hospital of Zhejiang Medical Colleage Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Treatment of CLL1-positive Hematological Malignancies
Administration of CLL1 CAR T-cells A dose levels of 2-8*10E6/kg are administrated for each subject.