Acute myeloid leukemia (AML) is a common type of acute leukemia in adults. Although the treatment of AML has improved in recent decades, the 5-year survival rate remains below 50% due to the chemoresistance or toxicity of these treatments. Most patients eventually die from relapse and/or progressive disease, and these patients urgently need new treatment strategies. Chimeric antigen receptor T-cell (CAR-T cell) therapy is an adoptive immunotherapy that expresses one or more specific chimeric antigen receptors (CARs) on T cells through genetic engineering, enabling them to target tumor cells. CAR-T cell immunotherapy has been a milestone in tumor immunotherapy in recent years and has achieved remarkable efficacy in the treatment of hematological malignancies. Human C-type lectin-like molecule 1 (CLL-1) is specifically expressed on the tumor cells of more than 90% of AML patients. CLL1 is selectively expressed on the surface of leukemia stem cells but not on normal hematopoietic stem cells, making it an ideal target for AML. Autologous CLL1 CAR-T cells have shown strong therapeutic effects in previous studies. However, autologous CAR-T cells have disadvantages such as long preparation time and high cost. Universal CAR-T cells have effectively solved this problem. In this study, universal CAR-T cells targeting the CLL1 target were prepared based on the non-gene editing intracellular membrane protein retention technology, further expanding the application of CAR-T in the treatment of acute myeloid leukemia.
The patient meets the diagnostic criteria for AML as per the 2022 WHO Fifth Edition Classification of Tumours of Haematopoietic and Lymphoid Tissues (WHO-HAEM5) and the definitions of relapse and refractory AML in the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)":Relapsed AML is defined as the reappearance of leukemia cells in the peripheral blood after achieving complete remission (CR), or the presence of more than 5% blasts in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemia cell infiltration in extramedullary sites.Refractory AML is defined as cases that do not respond to two standard treatment courses as initial therapy; cases that relapse within 12 months after achieving CR and consolidation therapy; cases that relapse after 12 months and do not respond to conventional chemotherapy; cases with two or more relapses; and cases with persistent extramedullary leukemia.
Diagnosis based on bone marrow and/or peripheral blood morphology within 28 days before enrollment.
Leukemia cells express CLL1 at a level greater than 50%.
Previous use of approved targeted drugs for relevant mutations.
Patients diagnosed with acute promyelocytic leukemia.
Patients who underwent autologous hematopoietic stem cell transplantation (SCT) within 6 weeks before enrollment.
Patients who received donor lymphocyte infusion (DLI) within 28 days before enrollment.
Patients with grade II-IV acute graft-versus-host disease (GVHD).
Single group
universal CLL1 CAR-T cells
Biological/VaccineInfusion of universal CLL1 CAR-T cells
Bone marrow tumor burden
At key time points following CAR-T cell infusion (e.g., Day 14), bone marrow samples are collected from patients via bone marrow puncture. The proportion of blast cells in the total bone marrow cells is calculated using flow cytometry to assess the therapeutic effect of CAR-T cells. A blast cell percentage of less than 5% is defined as complete remission.
Overall survival time
Overall survival time：Evaluate the time from CAR-T cell infusion to death or the end of follow-up for the patients.
Progression-Free-Survival
Progression-free survival time: The time interval from receiving CAR-T cell infusion to disease progression or death.
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Mingfeng Zhao
Lead sponsor
Tianjin First Central Hospital
Sponsor institution
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