Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06006403 | Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm | PHASE1 | RECRUITING | 36 | — | — | Aug 31, 2023 | Aug 31, 2026 | Aug 30, 2023 | 1 | China |
The incidence of adverse events after CD123 CAR-NK cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Objective response rate at 4W±7D and 3M±7D after CAR-NK infusion (Objective response rate includes CR, CRi)
| Arm | Type | Description |
|---|---|---|
| Acute Myeloid Leukemia | EXPERIMENTAL | Infusion of CD123-targeted CAR-NK cells by dose of 1-10x10\^6 cells/kg |
| Blastic Plasmacytoid Dendritic Cell Neoplasm | EXPERIMENTAL | Infusion of CD123-targeted CAR-NK cells by dose of 1-10x10\^6 cells/kg |
| Name | Type | Description |
|---|---|---|
| CD123 targeted CAR-NK cells | BIOLOGICAL | Administration method: intravenous infusion； Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. |
Inclusion Criteria: 1. Gender is not limited, age 18-75 years old (including the threshold value); 2. The expression of CD123 in tumor cells was detected by flow cytometry. 3. Patients with relapsed/refractory AML or BPDCN diagnosed with CD123 positive: 1) AML: a. Recurrent: After complete response...