Actively Recruiting
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
Led by Zhejiang University · Updated on 2023-09-07
24
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
H
Hangzhou Qihangene Biotech Co.,Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML)
- AML cells test positive for CLL1 expression
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with life expectancy over 12 weeks
- Adequate organ and marrow function including:
- Blood creatinine 2 times upper limit of normal (ULN) or creatinine clearance 2 50 mL/min
- Total bilirubin 2 times ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2 3 times ULN
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) 2 1.5 times ULN
- Females of childbearing potential must have a negative pregnancy test
- Negative donor specific antibody (DSA) with MFI 2 2000
- Signed and dated informed consent form
You will not qualify if you...
- Allergy to any drug used in this study
- Use of systemic steroid therapy within 3 days before first NK infusion (except physiological replacement)
- Systemic antitumor therapy within 2 weeks or less than 5 half-lives before first infusion
- Radiotherapy within 4 weeks prior to first infusion
- Donor lymphocyte infusion within 6 weeks before first infusion
- Intrathecal treatment within 1 week before first infusion
- CAR-T, CAR-NK, or other genetically modified cell therapy within 6 months before first infusion
- History of allogeneic stem cell transplantation
- Vaccination within 4 weeks prior to first infusion or expected vaccination during study to 12 weeks after last infusion
- Active central nervous system leukemia
- Acute promyelocytic leukemia (APL)
- History of other cancers unless complete remission for more than 5 years without recurrence
- Active autoimmune diseases
- History of central nervous system disease or meningeal involvement (e.g., epilepsy, paralysis, aphasia, stroke)
- Serious cardiovascular or cerebrovascular diseases including severe arrhythmias, recent acute coronary syndrome, heart failure, aortic dissection, stroke, uncontrolled hypertension
- Active lung infections or severe pulmonary conditions
- Uncontrolled bacterial, fungal, or viral infections, including known HIV, active hepatitis B or C
- History of substance abuse
- Unresolved toxicity from previous therapy above grade 2
- Major surgery within 4 weeks prior to first infusion (excluding biopsy)
- Pregnancy or breastfeeding
- Any medical or social condition that may interfere with study participation or increase risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
CONTACT
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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