Immunotherapy using modified NK cells for treating relapsed or refractory AML

CD123-Targeted CD16 Antibody-Modified NK Cell Immunotherapy for Refractory/Relapsed Acute Myeloid Leukemia (R/R AML)

This study is testing a new treatment using modified immune cells to see if it can help people with relapsed or hard-to-treat Acute Myeloid Leukemia feel better and achieve remission.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: immunotherapy, chemotherapy, Cyclophosphamide, Fludarabine
• Locations: 1 site (Beijing, China)
• Trial ID: NCT06835140 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with CD123-positive relapsed or refractory AML who have not responded to previous treatments.

Not a fit: Patients with Acute Promyelocytic Leukemia or those whose AML cells do not express CD123 may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed or refractory AML, potentially improving remission rates.

How similar studies have performed: While this approach is innovative, similar studies using NK cell therapies have shown promise in treating other hematological malignancies.

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.

Where this trial is running

Beijing, China

• Chinese PLA General Hospital — Beijing, China, China (RECRUITING)

Study contacts

• Study coordinator: Chunji Gao, M.D.

Conditions: AML, NK Cell, CD123+ Acute Myeloid Leukemia, CD123-CD16 bispecific antibody, NK cell, Refractory/relapsed AML