This study is a clinical trial designed to evaluate the safety and efficacy of a new type of CAR-T cell therapy for patients with relapsed/refractory acute myeloid leukemia (AML). The treatment involves modifying the patient's own T cells to target and eliminate leukemia cells more effectively. This is a cutting-edge therapy using anti-CLL1-CD33-NKG2D Bicephali CAR-T cells.
The primary goal of this study is to determine whether this treatment can improve survival and reduce the symptoms of AML in patients whose disease has not responded to standard treatments. Participants will be closely monitored for side effects and the overall effectiveness of the treatment.
Eligibility for this study includes patients who have been diagnosed with relapsed or refractory AML and have not had success with previous therapies. Participation in this study will provide access to an experimental treatment that may offer benefits beyond current treatment options, but also comes with risks.
Patients, their families, and healthcare providers will be provided with full information about the procedure, potential benefits, and risks, and they will have the opportunity to ask questions before deciding whether to participate.
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Single group
CAR-T
Biological/VaccineThis arm of the study involves the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells to patients with relapsed/refractory acute myeloid leukemia (AML). Patients will undergo apheresis to collect their T cells, which will then be genetically modified in the laboratory to express the anti-CLL1, CD33, and NKG2D receptors. The modified CAR-T cells will be reinfused into the patient to target and eliminate AML cells. This experimental treatment aims to evaluate the safety, efficacy, and immune response associated with this novel CAR-T therapy. Key endpoints include overall survival, progression-free survival, and response rates (such as complete remission or partial remission). Participants will be closely monitored for potential side effects, including cytokine release syndrome (CRS) and neurological toxicity, which are known risks of CAR-T cell therapy.
Rate of Complete Remission (CR) or Partial Remission (PR) in Patients with Relapsed/Refractory AML Following CAR-T Therapy
The primary outcome measure is the rate of complete remission (CR) or partial remission (PR) in patients with relapsed or refractory acute myeloid leukemia (AML) following the administration of anti-CLL1-CD33-NKG2D Bicephali CAR-T cells. CR and PR will be defined according to standard hematologic criteria, including complete resolution or reduction of leukemia cell counts and improvement in bone marrow function. This measure will be assessed using bone marrow biopsies and flow cytometry
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Xuzhou Medical University
Lead sponsor
Yake Biotechnology Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
