๐ฌIn plain words
What the trial is, and whether it could suit you
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๏ผ 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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ3 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 โฅ500 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.
๐
What it tests
- Donor-derived CD123-CD16 bispecific antibody-modified NK cells
Chinese PLA General Hospital
Beijing, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.
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