OncoMatch/Clinical Trials/NCT06027853
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
Is NCT06027853 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06027853 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic steroid therapy, systemic antitumor therapy, radiotherapy disqualifies patients from enrollment.
Does this trial require CLEC12A?
Yes, CLEC12A overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages