This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.
Patients are clinically diagnosed with relapsed or refractory acute myeloid leukemia；
Tumor cells are confirmed to be CD123 or CLL-1 positive by flow cytometry (FCM) or immunohistochemistry, with a positivity rate of no less than 80%；
Patients aged 18 to 75 years (inclusive)；
The expected survival time is more than 3 months from the date of signing the informed consent;
Within one - year prior to signing the informed consent form, there is a history of heart failure of New York Heart Association (NYHA) class ≥ III, or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other cardiac diseases with prominent clinical symptoms, or the QTc interval is > 480 ms during screening (the QTc interval is calculated by the Fridericia formula);
Those with active GvHD or those who need to use immunosuppressants;
Patients who have had any malignancy other than acute myeloid leukemia (AML) within the past 5 years, except for those with adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally resected prostate cancer, or resected ductal carcinoma in situ of the breast;
Patients who have active infections requiring systemic treatment or uncontrollable infections within 7 days prior to screening, except for mild urinary and genital infections and upper respiratory infections;
Single group
CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic
Biological/VaccineFor patients with refractory and relapsed AML, CD123+CLL-1 dual-target CAR-T cells (JY017) are used for treatment. Then, for patients who cannot achieve the minimum residual negative, CD7-targeted CAR-T cells (JY008) are sequentially infused. Finally, allogeneic hematopoietic stem cell transplantation is performed based on patient conditions.
Monitor and record adverse events
Overall Response Rate
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This trial is not recruiting at the moment. You can still explore other options:
