This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.
Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;
Aged from 18 to 70 years (including cut-off value), Male and female;
Expected survival > 12 weeks;
AML patients who have not achieved complete remission (CR) after at least three cycles of standard induction therapy, or
Diagnosed as acute promyelocytic leukemia (APL M3);
With any presence of other uncontrolled malignancies (unless evaluated as unlikely to interfere with the safety or efficacy assessment of the trial);
Previously treated with CAR-T cells or other genetically modified cellular therapies
Displayed history or evidence of significant cardiovascular risks, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia), coronary angioplasty within 6 months before administration, implantable cardiac defibrillator, or any clinically relevant comorbidities that pose safety risks or interfere with study assessments, procedures, or completion;
Single group
Human Derived anti-CI135 CAR-T Injection
DrugAutologous genetically modified anti-CI135 CAR transduced T cells
Dose limited toxicity (DLT)
Safety Indicator
Pharmacokinetics parameters - Maximum CAR level in peripheral blood (Cmax)
Effectiveness Metrics
Pharmacokinetics parameters -Time to maximum CAR level in peripheral blood (Tmax)
Effectiveness Metrics
Pharmacokinetics parameters - 28-day Area under Curve of CAR level in peripheral blood (AUC0-28)
Effectiveness Metrics
Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level in peripheral blood
Effectiveness Metrics, determined via ELISA, including but not limited to: Interleukin-15 (IL-15) by pg/μl blood sample; Interleukin-6 (IL-6) by pg/μl blood sample; Granzyme B by pg/μl blood sample; Interferon-γ (IFN-γ) by pg/μl blood sample; Tumor Necrocis Factor α (TNF-α) by pg/μl blood sample;
HAMA Immunogenicity
Determination of the immunogenicity via human anti-mouse antibodies.
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Hrain Biotechnology Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
