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Clinical Trials in China / NCT06835140
Recruiting Phase 1

CD123-CD16-NK Cells Immunotherapy for AML

NCT06835140 · tracked via the Priya Life Science China tracker
Sponsor
Chunji Gao
Phase
Phase 1
Started
2025-02-21
Last updated
2025-02-25

Condition(s) studied

AML (Acute Myelogenous Leukemia)NK CellCD123+ Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

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

Donor-derived CD123-CD16 bispecific antibody-modified NK cells: Patients enrolled sequentially received varying doses of NK cell infusions. The first three patients received 1×10⁷ cells/kg, the next three received 2×10⁷ cells/kg, and the final three received 4×10⁷ cells/kg.

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • ORR — Bone marrow aspiration assessments are conducted one week after each patient's treatment completion, followed by evaluations at 1 month, 3 months, and 6 months.
    Overall Response Rate
  • CR — Bone marrow aspiration assessments are conducted one week after each patient's treatment completion, followed by evaluations at 1 month, 3 months, and 6 months.
    Complete Remission Rate
  • AE — 14 days-28 days after infusion
    Adverse events related to cell reinfusion (≥ Grade 3 treatment-related organ toxicity, laboratory tests, and Grade 4 hematologic toxicity, etc.) and number of participants with treatment-related AEs assessed by CTCAE v5.0

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing China Recruiting

Other trials for the same condition

Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT Recruiting
Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma Starting soon
The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT Recruiting
A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined With Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation. Recruiting
The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06835140 on ClinicalTrials.gov ↗ ← All trials in China