CD123-CD16-NK Cells Immunotherapy for AML

Last updated: February 23, 2025
Sponsor: Chunji Gao
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia

Treatment

Donor-derived CD123-CD16 bispecific antibody-modified NK cells

Clinical Study ID

NCT06835140
S2024-653-01
  • Ages 18-70
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 multiplefirst-line clinical treatments and has developed resistance to current treatments.Relapse after original induction therapy failure with a predicted survival of morethan three months.

  3. CD123 Expression: Flow cytometry detection shows CD123-positive AML cells.CD123 expression level isnot less than 20%.

  4. Hospital Examination Criteria:

  5. Performance Status: ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) scoregreater than 80.

  6. Donor Availability:

  7. Have a suitable healthy donor and agree to peripheral blood collection.

Exclusion

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 previoustreatments.

  4. GVHD Requiring Immunosuppression: Patients requiring immunosuppressants for grade II-IV acute Graft-Versus-HostDisease (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 steroidtreatment).

  6. Severe Cardiovascular and Cerebrovascular Diseases: Certain cardiovascular and cerebrovascular diseases within 6 months prior to firstdose. New York Heart Association (NYHA) classification ≥3 or uncontrolled malignantarrhythmias.Other cardiovascular and cerebrovascular diseases deemed unsuitable bythe investigator.

  7. Pregnancy and Lactation: Pregnant or breastfeeding women (the safety of this treatment for unborn babies isunknown). For female participants, pregnancy must be confirmed negative by serum or urinepregnancy test within 48 hours before infusion.

  8. Infections: Active Hepatitis B,Hepatitis C virus infection, Peripheral blood CMV-DNA ≥500copies/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.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Donor-derived CD123-CD16 bispecific antibody-modified NK cells
Phase: 1
Study Start date:
February 21, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, 100853
    China

    Active - Recruiting

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