Relapsed/refractory acute myeloid leukemia (AML) currently lacks effective CAR-T therapy products due to the absence of specific target antigens. Most AML antigens are frequently expressed in normal hematopoietic stem/progenitor cells (HSPCs) or healthy organ tissues, thereby increasing the risks of target toxicity and non-neoplastic toxicity. CD33 is expressed in leukemia cells from over 80% of AML patients. Compared to other targets such as CLL-1 and CD123, CD33 typically exhibits higher expression levels across various AML subtypes, reducing the risk of treatment failure and relapse caused by tumor antigen escape, making it an ideal therapeutic target for AML. However, conventional CD33 CAR-T therapies have demonstrated suboptimal efficacy in clinical trials and face challenges such as toxicity and insufficient expansion. To further investigate the safety and efficacy of CAR-T therapy for AML, our center has initiated a clinical study on functionally optimized CD33 CAR-T (FO33 CAR-T) cell therapy for refractory/refractory AML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Functionally optimized CD33 CAR-T intravenous infusion
Evaluate the safety of Functionally optimized CD33 CAR-T cell therapy in relapsed/refractory B Cell Acute Myeloid Leukemia
the incidence and severity of immune therapy related toxic reactions (irAEs)
Time frame: up to one month after the CAR-T infusion
Evaluate the effcacy of Functionally optimized CD33 CAR-T cell therapy in relapsed/refractory B Cell Acute Myeloid Leukemia
CR rate on M1 and M3
Time frame: one month and three month after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
long-term efficacy
OS
Time frame: up to one year after the CAR-T infusion
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