CD123-CD16-NK Cells Immunotherapy for AML
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
| Condition(s) | AML (Acute Myelogenous Leukemia), NK Cell, CD123+ Acute Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. Age: Between18 years and 70 years. 2. Diagnosis and Treatment History: Diagnosed with Acute Myeloid Leukemia (AML) in the hospital. Has undergone multiple first-line clinical treatments and has developed resistance to current treatments. Relapse after original induction therapy failure with a predicted survival of more than three months. 3. CD123 Expression: Flow cytometry detection shows CD123-positive AML cells.CD123 expression level is not less than 20%. 4. Hospital Examination Criteria: 5. Performance Status: ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) score greater than 80. 6. Donor Availability: 7. Have a suitable healthy donor and agree to peripheral blood collection. Exclusion Criteria: 1. Specific AML Subtype: Diagnosed with Ac |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Chunji Gao |
| Locations | Beijing, China, China |
| Start date | 2025-02-21 |
| NCT ID | NCT06835140 |
| Official listing | https://clinicaltrials.gov/study/NCT06835140 |