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 (Jun 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid 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)
Demographics
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.
Frequently asked questions
Is NCT06006403 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, investigational drug disqualifies patients from enrollment.
Does this trial require IL3RA?
Yes, IL3RA overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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