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OncoMatch/Clinical Trials/NCT06367673

Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia

Is NCT06367673 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies iPSC-NK cells for aml, adult.

Phase 1RecruitingZhejiang UniversityNCT06367673Data as of Jun 2026Location: China

Treatment: iPSC-NK cellsThis is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML

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Extracted eligibility criteria

Treatments studied

Other

iPSC-NK cells

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: CLL1 expression is positive in AML blasts (positive)

CLL1 or CD33 expression is positive in AML blasts

Required: CD33 expression is positive in AML blasts (positive)

CLL1 or CD33 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 product

CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months

Lab requirements

Blood counts

Adequate marrow function (details not specified)

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

Adequate organ and marrow function, as defined below: 1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min; 2. Total bilirubin (TBIL) ≤ 2 x the ULN; 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; 4. 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 NCT06367673 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 CLL1?

Yes, CLL1 expression is positive in AML blasts is a required biomarker for enrollment.

Does this trial require CD33?

Yes, CD33 expression is positive in AML blasts 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.

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