OncoMatch/Clinical Trials/NCT06027853
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
Is NCT06027853 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CLL1 CAR-NK cell for aml, adult.
Treatment: CLL1 CAR-NK cell — This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A overexpression (positive in AML blasts)
CLL1 expression is positive in AML blasts
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic steroid therapy
Exception: physiological replacement therapy
Systemic steroid therapy within 3 days (except physiological replacement therapy)
Cannot have received: systemic antitumor therapy
Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less
Cannot have received: radiotherapy
Radiotherapy within 4 weeks
Cannot have received: donor lymphocyte infusion
Donor lymphocyte infusion within 6 weeks
Cannot have received: intrathecal treatment
Intrathecal treatment within 1 week
Cannot have received: CAR-T cell therapy
CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months
Cannot have received: CAR-NK cell therapy
CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months
Cannot have received: genetically modified cell therapy
CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months
Lab requirements
Blood counts
Adequate marrow function (see protocol for specifics)
Kidney function
Blood creatinine ≤ 2 x ULN or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min
Liver function
Total bilirubin ≤ 2 x ULN; ALT and AST ≤ 3 x ULN; INR and aPTT ≤ 1.5 x ULN
Cardiac function
No serious cardiovascular and cerebrovascular diseases as defined in exclusion criteria
Adequate organ and marrow function, as defined below: Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min; Total bilirubin (TBIL) ≤ 2 x the ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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