Actively Recruiting
The Safety and Efficacy for Anti-human CLL-1 CAR-NK Cells in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-09-30
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating anti-human CLL-1 CAR NK cells in adults aged 18 to 70 years with relapsed or refractory acute myeloid leukemia (AML). This phase 1, open-label, single-arm dose-escalation trial aims to assess the safety, tolerability, and pharmacokinetics of these engineered cells, along with early observations on their potential effectiveness in this patient group. The study is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Participants will receive a single dose infusion of CLL-1 CAR NK cells after lymphocyte collection from themselves or a donor and successful cell preparation. Four different dose levels will be tested, ranging from 5x10^6 to 4x10^7 CAR-NK cells per kilogram of body weight. The treatment process involves a careful escalation of doses to monitor safety and response. During the study, patients will be closely monitored for adverse events and dose-limiting toxicities between 14 and 28 days after infusion. Researchers will measure drug levels in plasma, evaluate response to treatment, and track survival outcomes for up to two years. Additional assessments include progression-free and overall survival, duration of response, and treatment-related side effects. Participants will also undergo evaluations of organ function and ability to tolerate the therapy throughout the study.
CONDITIONS
Brief Title
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Expected survival time longer than 12 weeks
- ECOG performance status score between 0 and 2
- Confirmed acute myeloid leukemia per 2022 WHO criteria with at least 70% CLL1 expression by flow cytometry or 50% by immunohistochemistry
- Meet relapse criteria: bone marrow primitive cells over 5% after remission or extramedullary lesions, including early relapse within 12 months or late relapse after salvage chemotherapy without remission
- Meet refractory criteria: no complete remission after specified chemotherapy regimens or salvage treatment including targeted therapy
- Able to undergo lymphocyte collection and leukapheresis
- Adequate liver, kidney, heart, and lung function as specified
- Able to understand and sign informed consent
You will not qualify if you...
- Presence of AML with PML-RARA fusion gene
- History of other malignancies within 5 years except certain treated cancers
- Uncontrolled active infections including hepatitis B, hepatitis C, syphilis, or HIV
- Significant cardiovascular or pulmonary dysfunction or recent major cardiovascular events
- Active gastrointestinal bleeding within 3 months
- Uncontrolled active diseases hindering trial participation
- Active or uncontrolled central nervous system disease requiring treatment
- Recent systemic corticosteroid therapy or use of PD-1/PD-L1 antibodies within 3 months
- Pregnant or breastfeeding women or those planning pregnancy within 1 year
- Previous CAR-T or gene-modified cell therapy
- Post-allogeneic transplant patients with recent immunosuppressive drug use
- Known allergies to study treatment components or chemotherapy agents
- Any condition compromising safety, study compliance, or ability to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after infusion
Participants receive lymphocyte collection followed by a single dose infusion of anti-CLL-1 CAR NK cells at one of four dose levels.
1 lymphocyte collection visit and 1 infusion visit
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and survival outcomes for up to 2 years after treatment.
Regular follow-up visits according to study schedule
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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