NCT06690827 Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN
| NCT ID | NCT06690827 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chongqing Precision Biotech Co., Ltd |
| Condition | AML (Acute Myeloid Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2027-10-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients of any gender, aged between 18 and 75 years (inclusive); 2. Positive expression of CD123 on tumor cells detected by flow cytometry; 3. 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 t
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