NCT06367673 Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia
| NCT ID | NCT06367673 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhejiang University |
| Condition | AML, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2026-03-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This 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
Eligibility Criteria
Inclusion Criteria: * ≥18 years old. * Confirmed diagnosis of r/r AML * CLL1 or CD33 expression is positive in AML blasts. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks. * 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 6.Females of childbearing potential must have a negative serum pregnancy test. 7.Donor specific antibody (DSA) is negative: MFI \<= 2000. 8.Provision of signed and dated informed consent form (ICF). Exclusion Criteria: * Allergic to drug used in this study. * Subjects received any antitumor therapy as follows, prior to first NK infusion: a. Systemic steroid therapy within 3 d