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New treatment option for AML (Acute Myelogenous Leukemia)
Official title CD123-CD16-NK Cells Immunotherapy for AML
ClinicalTrials.gov ID: NCT06835140
What this study is testing
What is Donor-derived CD123-CD16 bispecific antibody-modified NK cells?
Donor-derived CD123-CD16 bispecific antibody-modified NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aml (acute myelogenous leukemia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age: Between18 years and 70 years.
- Diagnosis and Treatment History: Diagnosed with Acute Myeloid Leukemia (AML) in the hospital. Has undergone multiple first-line clinical treatments...
- CD123 Expression: Flow cytometry detection shows CD123-positive AML cells.CD123 expression level is not less than 20%.
- Hospital Examination Criteria:
- Performance Status: ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) score greater than 80.
You likely can't join if
- Specific AML Subtype: Diagnosed with Acute Promyelocytic Leukemia(APL).
- CD123 Expression: Flow cytometry shows CD123 negative or CD123 expression level less than 20%.
- Prior Treatment Toxicity: Persistent non-hematologic toxicity of grade 2 or higher related to previous treatments.
- GVHD Requiring Immunosuppression: Patients requiring immunosuppressants for grade II-IV acute Graft-Versus-Host Disease (GVHD).
- Recent Steroid Treatment: Systemic steroid treatment within 7 days prior to first study drug treatment (excluding topical and inhaled corticosteroids...
- Severe Cardiovascular and Cerebrovascular Diseases: Certain cardiovascular and cerebrovascular diseases within 6 months prior to first dose. New York...
See the full eligibility criteria
- Age: Between18 years and 70 years.
- 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...
- CD123 Expression: Flow cytometry detection shows CD123-positive AML cells.CD123 expression level is not less than 20%.
- Hospital Examination Criteria:
- Performance Status: ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) score greater than 80.
- Donor Availability:
- Have a suitable healthy donor and agree to peripheral blood collection.
- Specific AML Subtype: Diagnosed with Acute Promyelocytic Leukemia(APL).
- CD123 Expression: Flow cytometry shows CD123 negative or CD123 expression level less than 20%.
- Prior Treatment Toxicity: Persistent non-hematologic toxicity of grade 2 or higher related to previous treatments.
- GVHD Requiring Immunosuppression: Patients requiring immunosuppressants for grade II-IV acute Graft-Versus-Host Disease (GVHD).
- 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).
- 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...
- 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...
- Infections: Active Hepatitis B,Hepatitis C virus infection, Peripheral blood CMV-DNA ≥500 copies/mL, HIV/AIDS infection and any uncontrolled active infection.
- Allergic Reactions: Allergic to immunotherapy and related drugs.
- Neurological Diseases: Neurological diseases such as neurodegenerative diseases, primary central nervous system tumors/infections, multiple sclerosis, epilepsy, severe peripheral neuropathy, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.