Immunotherapy using modified NK cells for treating relapsed or refractory AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of CD123-CD16 bispecific antibody-modified NK cells in patients with relapsed or refractory Acute Myeloid Leukemia (AML). Participants will undergo lymphocyte-depleting chemotherapy before receiving intravenous infusions of modified NK cells at escalating doses. The study will compare the outcomes of this novel therapy against existing treatment options to assess its efficacy and safety profile. The primary focus is to determine if this approach can induce remission in patients with CD123-positive AML.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese PLA General Hospital
  Beijing, China, China Recruiting

Study contacts

• Study coordinator: Chunji Gao, M.D.
• Email: gaochunji301@163.com
• Phone: +86 13911536256

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.