The goal of this clinical trial is to evaluate the effectiveness of CD123-CD16 bispecific antibody-modified NK cells in treating patients with CD123-positive relapsed or refractory Acute Myeloid Leukemia (RR AML). It will also assess the safety of this modified NK cell therapy. The main questions： Does the infusion of CD123-CD16 bispecific antibody-modified NK cells induce remission in RR AML patients? What are the safety and potential adverse effects associated with the administration of these modified NK cells? Researchers will administer CD123-CD16 bispecific antibody-modified NK cells to RR AML patients and compare the outcomes to existing treatment options to determine efficacy and safety. Participants will: Undergo lymphocyte-depleting chemotherapy Fludarabine\&Cyclophosphamide from day -5 to day -3 before NK cell infusion. Receive intravenous infusions of modified NK cells at escalating doses: The first three patients will receive 1×10⁷ cells/kg. The next three patients will receive 2×10⁷ cells/kg. The final three patients will receive 4×10⁷ cells/kg. Have NK cell infusions administered every 96-120 hours for a total of three infusions, with each infusion completed within 10 to 15 minutes. Undergo dose escalation with subsequent groups only after confirming the safety of the previous dose group. Have their vital signs (temperature, heart rate, respiratory rate, blood pressure, etc.) monitored before and after each infusion. Keep baseline data records during NK cell infusions. Participate in follow-up assessments to monitor disease remission and detect any adverse events. This trial aims to provide new treatment options for RR AML patients by leveraging the targeted cytotoxic effects of CD123-CD16 bispecific antibody-modified NK cells to achieve disease remission.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Patients enrolled sequentially received varying doses of NK cell infusions. The first three patients received 1×10⁷ cells/kg, the next three received 2×10⁷ cells/kg, and the final three received 4×10⁷ cells/kg.
Chinese PLA General Hospital
Beijing, China, China
RECRUITINGORR
Overall Response Rate
Time frame: Bone marrow aspiration assessments are conducted one week after each patient's treatment completion, followed by evaluations at 1 month, 3 months, and 6 months.
CR
Complete Remission Rate
Time frame: Bone marrow aspiration assessments are conducted one week after each patient's treatment completion, followed by evaluations at 1 month, 3 months, and 6 months.
AE
Adverse events related to cell reinfusion (≥ Grade 3 treatment-related organ toxicity, laboratory tests, and Grade 4 hematologic toxicity, etc.) and number of participants with treatment-related AEs assessed by CTCAE v5.0
Time frame: 14 days-28 days after infusion
Progressive Disease (PD)
PD parameters: content of CD123+AML cells in peripheral blood ; plasma cytokine levels at various time points;
Time frame: 14 days-28 days after infusion
Stable Disease (SD)
the condition without significant progression nor significant reduction in AML cells after treatment. The disease is stable, with no significant change in the number of leukemia cells in peripheral blood or bone marrow assessed by IRC.
Time frame: 14 days-28 days after infusion
Progression-free survival (PFS)
the time from cell last infusion to the first assessment of tumor progression, relapse, or death for any reason
Time frame: through study completion, an average of 6-12moths
Overall survival (OS)
the time from cell last infusion to death for any reason
Time frame: through study completion, an average of 6-12moths
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