Tests CD123-targeted CAR-NK cells in relapsed or refractory leukemia or BPDCN
Tests engineered immune cells targeting CD123 in adults with returned or non-responding leukemia.
Plain-language title generated from the registry record
Registry title: Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/Refractory AML or BPDCN
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06690827, who can take part
Where in China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chongqing Precision Biotech Co., Ltd
- Trial code
- NCT06690827
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)
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.
Inclusion: 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 chemotherapy), or the presence of leukemic cell infiltration outside the marrow; 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 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia; (2) For BPDCN patients: Patients who have not responded to or cannot tolerate the recommended salvage treatment according to guidelines, and have persistent or recurrent disease in any of the following: peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other sites; Expected survival time of more than 12 weeks; ECOG score of 0-2 (Appendix 2); No severe mental disorders; Basic normal function of important organs:; 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 and willingness to participate in the study.
Exclusion: 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 have confirmed disease progression after treatment; 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; Receipt of live attenuated vaccines within 4 weeks prior to screening; Pregnant or breastfeeding women, as well as male or female subjects who plan to have children within 1 year after receiving CAR-NK cell infusion; 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 situ after radical surgery; Other conditions that the investigator deems unsuitable for participation in the study; Presence of active central nervous system invasion during screening.