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Tests treatment safety and results for Acute Myeloid Leukemia
Official title Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
ClinicalTrials.gov ID: NCT06006403
What this study is testing
What is CD123 targeted CAR-NK cells?
CD123 targeted CAR-NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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 study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed/refractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed/refractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.
- Phase 2: a mid-size study of how well it works
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
- Gender is not limited, age 18-75 years old (including the threshold value);
- The expression of CD123 in tumor cells was detected by flow cytometry.
- Patients with relapsed/refractory AML or BPDCN diagnosed with CD123 positive: 1) AML: a. Recurrent: After complete response (CR), the recurrence of...
- Cardiac function: echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
- Renal function: serum creatinine ≤2.0×ULN;
You likely can't join if
- Prior to screening, the following anti-tumor therapies were received: chemotherapy, targeted therapy, or other investigational drug treatment within...
- had a cerebrovascular accident or seizure within 6 months before signing the ICF;
- There is an active or uncontrolled infection that requires systemic treatment within 1 week prior to screening;
- suffering from any of the following heart diseases:
- New York Heart Association (NYHA) Stage III or IV congestive heart failure;
- Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;
See the full eligibility criteria
- Gender is not limited, age 18-75 years old (including the threshold value);
- The expression of CD123 in tumor cells was detected by flow cytometry.
- Patients with relapsed/refractory AML or BPDCN diagnosed with CD123 positive: 1) AML: a. Recurrent: After complete response (CR), the recurrence of leukemia cells in peripheral blood or bone marrow original cells ≥5%...
- Cardiac function: echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
- Renal function: serum creatinine ≤2.0×ULN;
- Liver function: ALT and AST ≤ 3.0×ULN;
- Total bilirubin and alkaline phosphatase ≤ 2.0×ULN (Gilbert syndrome ≤ 3.0×ULN);
- Blood oxygen saturation \> 92%. 7\. The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and...
- Prior to screening, the following anti-tumor therapies were received: chemotherapy, targeted therapy, or other investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter), except in...
- had a cerebrovascular accident or seizure within 6 months before signing the ICF;
- There is an active or uncontrolled infection that requires systemic treatment within 1 week prior to screening;
- suffering from any of the following heart diseases:
- New York Heart Association (NYHA) Stage III or IV congestive heart failure;
- Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;
- A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy;
- combined with active hepatitis B;
- Combined with active autoimmune diseases, long-term immunosuppressive therapy is required;
- have other malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
- Had received live attenuated vaccine within 4 weeks prior to screening;
- Women who are pregnant or breastfeeding, and male or female people who plan to have a family within 1 year after receiving CAR T cell transfusion;
- Circumstances deemed unsuitable for participation in the study by other researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, 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 Taiyuan, Shanxi, 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.