CD123-CD16-NK Cells Immunotherapy for AML

Launched by CHUNJI GAO · Feb 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a type of blood cancer called Acute Myeloid Leukemia (AML) that has come back or has not responded to previous treatments. The researchers are testing a special therapy that uses modified immune cells, known as NK cells, to target and destroy the cancer cells. The main goal is to see if these modified NK cells can help patients achieve remission, which means the cancer is no longer detectable. They will also monitor the safety of this treatment and any side effects it may cause.

To be eligible for this trial, participants must be between 18 and 70 years old, have been diagnosed with AML, and have had previous treatments that did not work. They need to have a specific marker on their cancer cells called CD123. Participants will receive a type of chemotherapy before getting the NK cells, followed by infusions of these modified cells over a few days. Throughout the process, their health will be closely monitored. This trial offers a potential new option for patients whose current treatments are not effective.

Gender

ALL

Eligibility criteria

• 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 Acute Promyelocytic Leukemia(APL).
• 2. CD123 Expression:
• • Flow cytometry shows CD123 negative or CD123 expression level less than 20%.
• 3. Prior Treatment Toxicity:
• • Persistent non-hematologic toxicity of grade 2 or higher related to previous treatments.
• 4. GVHD Requiring Immunosuppression:
• • Patients requiring immunosuppressants for grade II-IV acute Graft-Versus-Host Disease (GVHD).
• 5. Recent Steroid Treatment:
• • Systemic steroid treatment within 7 days prior to first study drug treatment (excluding topical and inhaled corticosteroids or short-term prophylactic steroid treatment).
• 6. Severe Cardiovascular and Cerebrovascular Diseases:
• • Certain cardiovascular and cerebrovascular diseases within 6 months prior to first dose.
• • New York Heart Association (NYHA) classification ≥3 or uncontrolled malignant arrhythmias.Other cardiovascular and cerebrovascular diseases deemed unsuitable by the investigator.
• 7. Pregnancy and Lactation:
• • Pregnant or breastfeeding women (the safety of this treatment for unborn babies is unknown).
• • For female participants, pregnancy must be confirmed negative by serum or urine pregnancy test within 48 hours before infusion.
• 8. Infections:
• • Active Hepatitis B,Hepatitis C virus infection, Peripheral blood CMV-DNA ≥500 copies/mL, HIV/AIDS infection and any uncontrolled active infection.
• 9. Allergic Reactions:
• • Allergic to immunotherapy and related drugs.
• 10. Neurological Diseases:
• • Neurological diseases such as neurodegenerative diseases, primary central nervous system tumors/infections, multiple sclerosis, epilepsy, severe peripheral neuropathy, etc.