OncoMatch/Clinical Trials/NCT06006403
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Is NCT06006403 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD123 targeted CAR-NK cells for acute myeloid leukemia.
Treatment: CD123 targeted CAR-NK cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: IL3RA overexpression (CD123 positive by flow cytometry)
The expression of CD123 in tumor cells was detected by flow cytometry. Patients with relapsed/refractory AML or BPDCN diagnosed with CD123 positive
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard protocols — AML: refractory defined as failed 2 courses of treatment with standard protocols
refractory: refers to those who have failed to receive 2 courses of treatment with standard protocols
Must have received: guidelines-recommended salvage therapy — BPDCN: failed or unable to tolerate
BPDCN: has failed to receive guidelines-recommended salvage therapy or is unable to tolerate current therapy
Cannot have received: chemotherapy
Exception: except in cases where disease progression has been confirmed after treatment
chemotherapy, targeted therapy, or other investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter), except in cases where disease progression has been confirmed after treatment
Cannot have received: targeted therapy
Exception: except in cases where disease progression has been confirmed after treatment
chemotherapy, targeted therapy, or other investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter), except in cases where disease progression has been confirmed after treatment
Cannot have received: investigational drug
Exception: except in cases where disease progression has been confirmed after treatment
chemotherapy, targeted therapy, or other investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter), except in cases where disease progression has been confirmed after treatment
Lab requirements
Kidney 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)
Cardiac function
echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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