Actively Recruiting
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-09-30
24
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Expected survival time longer than 12 weeks
- ECOG performance status score between 0 and 2
- Diagnosed with acute myeloid leukemia meeting 2022 WHO criteria with 70% CLL-1 expression by flow cytometry, or 50% by immunohistochemistry with specific relapse or refractory conditions
- Able to establish venous access for cell collection and no contraindications for leukapheresis
- Liver, kidney, heart, and lung function within specified limits, including creatinine clearance 60 mL/min, ejection fraction over 50%, blood oxygen saturation above 92%, and liver enzymes within limits
- Able to understand and sign informed consent form
You will not qualify if you...
- Presence of AML with PML-RARA fusion gene
- History of malignancies other than AML within 5 years, except certain treated cancers
- Uncontrolled active infections including bacterial, viral, or fungal infections; positive viral markers for HBV, HCV, syphilis, or HIV
- Significant cardiovascular or pulmonary dysfunction or recent serious events such as stroke, deep vein thrombosis, or pulmonary embolism
- Any uncontrolled active disease preventing trial participation
- Active or uncontrolled central nervous system disease requiring treatment
- Use of systemic corticosteroids before screening or requiring long-term use during study, excluding local or inhaled use
- Use of PD-1 or PD-L1 monoclonal antibodies within 3 months before enrollment
- Pregnant or lactating women or planning pregnancy within 1 year after infusion
- Prior CAR-T or gene-modified cell therapy
- Post-allogeneic transplantation patients with unresolved significant graft-versus-host disease or recent immunosuppressive drug use
- Known allergies to components of the study treatments
- Any condition or situation that compromises safety or study compliance, or inability to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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