Actively Recruiting
Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia
Led by Zhejiang University · Updated on 2024-04-18
24
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
H
Hangzhou Qihanjiyin 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 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML
CONDITIONS
Official Title
Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 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 AML
- AML blasts test positive for CLL1 or CD33
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than 12 weeks
- Adequate organ and bone marrow function as defined by study criteria
- Negative pregnancy test for females of childbearing potential
- Negative donor specific antibody (DSA) test with MFI ≤ 2000
- Signed and dated informed consent form
You will not qualify if you...
- Allergy to any drug used in this study
- Recent systemic steroid therapy within 3 days (except physiological replacement)
- Systemic antitumor therapy within 2 weeks or 5 half-lives, whichever is less
- Radiotherapy within 4 weeks
- Donor lymphocyte infusion within 6 weeks
- Intrathecal treatment within 1 week
- Prior CAR-T, CAR-NK, or other genetically modified cell therapy within 6 months
- History of allogeneic stem cell transplantation
- Vaccination within 4 weeks before first infusion or expected vaccination during study period plus 12 weeks
- Active central nervous system leukemia
- Acute Promyelocytic Leukemia (APL)
- History of malignant tumors unless complete remission over 5 years without recurrence
- History of central nervous system disease or meningeal involvement
- Active autoimmune diseases
- Serious cardiovascular or cerebrovascular diseases as defined by study criteria
- Active pulmonary infection or severe lung diseases
- Uncontrolled bacterial, fungal, or viral infection
- Known HIV, active Hepatitis B or C infection
- History of substance abuse
- Toxicity from prior therapy not recovered to grade 2 or better
- Large surgical treatment within 4 weeks prior to first infusion, excluding biopsy
- Pregnant or breastfeeding women
- Any medical or social condition that could interfere with the study or increase risk to participant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 321000
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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