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New treatment option for AML (Acute Myeloid Leukemia)
Official title Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN
ClinicalTrials.gov ID: NCT06690827
What this study is testing
What is Anti-CD123 CAR NK cells?
Anti-CD123 CAR NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aml (acute myeloid 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
- This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.
- 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 75
You may be able to join if
- Patients of any gender, aged between 18 and 75 years (inclusive);
- Positive expression of CD123 on tumor cells detected by flow cytometry;
- Patients with a confirmed diagnosis of CD123-positive relapsed/refractory AML or BPDCN: (1) For AML patients：
- Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding...
- Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and...
You likely can't join if
- Presence of active central nervous system invasion during screening;
- Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or...
- Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;
- Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;
- Presence of any of the following cardiac diseases:
- Congestive heart failure at New York Heart Association (NYHA) class III or IV;
See the full eligibility criteria
- Patients of any gender, aged between 18 and 75 years (inclusive);
- Positive expression of CD123 on tumor cells detected by flow cytometry;
- Patients with a confirmed diagnosis of CD123-positive relapsed/refractory AML or BPDCN: (1) For AML patients：
- Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation...
- Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation/intensification therapy; patients who have relapsed after...
- Blood routine: white blood cells \>1.0×109/L, neutrophils \>0.5×109/L, lymphocytes \>0.5×109/L, platelets \>50×109/L;
- Cardiac function: echocardiography indicates a left ventricular ejection fraction ≥50%, and no significant abnormalities on electrocardiogram;
- Renal function: serum creatinine ≤2.0×ULN;
- Liver function: ALT and AST ≤3.0×ULN (for patients with liver invasion
- 5.0×ULN);
- Total bilirubin ≤2.0×ULN (for patients with Gilbert's syndrome ≤3.0×ULN);
- Blood oxygen saturation \>92%. 8. The patient or their legal guardian agrees to participate in this clinical trial and signs the ICF, indicating their understanding of the purpose and procedures of the clinical trial...
- Presence of active central nervous system invasion during screening;
- Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter), except for those who...
- Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;
- Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;
- Presence of any of the following cardiac diseases:
- Congestive heart failure at New York Heart Association (NYHA) class III or IV;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;
- Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding cases caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy;
- Combination with active autoimmune diseases requiring long-term immunosuppressive therapy;
- Presence of other malignancies, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in...
- Receipt of live attenuated vaccines within 4 weeks prior to screening;
- Pregnant or breastfeeding women, as well as male or female people who plan to have children within 1 year after receiving CAR-NK cell infusion;
- Other conditions that the investigator deems unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.