OncoMatch/Clinical Trials/NCT06307054
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
Is NCT06307054 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies anti-CLL-1 CAR NK cells for relapsed adult aml.
Treatment: anti-CLL-1 CAR NK cells — This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A overexpression (≥70% by flow cytometry OR ≥50% by immunohistochemistry)
flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry shows CLL1 expression ≥50%
Excluded: PML fusion with RARA
Confirmed AML with PML-RARA fusion gene
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: targeted therapy — relapsed
Salvage treatment for all relapsed patients should include at least one course of targeted therapy without achieving remission
Must have received: standard intensive chemotherapy (3+7 regimen) — refractory
No complete remission after two courses of standard intensive chemotherapy based on the 3+7 regimen, and no complete remission after second-line salvage chemotherapy or treatment including targeted therapy
Must have received: purine analog induction chemotherapy (FLAG-Ida, CLIA) — refractory
no complete remission after one course of purine analog induction chemotherapy (such as FLAG-Ida, CLIA, or similar regimens), and no complete remission after salvage treatment or treatment including targeted therapy
Must have received: low-intensity treatment based on HMA (including venetoclax) (venetoclax) — refractory
no complete remission after three cycles of low-intensity treatment based on HMA, including low-intensity regimens containing venetoclax
Cannot have received: CAR-T therapy or other gene-modified cell therapy
Subjects who have received CAR-T therapy or other gene-modified cell therapy in the past
Lab requirements
Kidney function
creatinine clearance ≥ 60 ml/min or creatinine ≤ 2.5×uln
Liver function
total bilirubin ≤ 3×uln; alt and ast ≤ 3×uln
Cardiac function
ejection fraction >50%, no clinically significant electrocardiogram changes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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