Status:
RECRUITING
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Hangzhou Qihangene Biotech Co.,Ltd.
Conditions:
AML, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 target CAR iPSC NK cells in patients with relapsed/refracto...
Detailed Description
Acute myelogenous leukemia (AML) is a potentially cur-able disease; 70% of newly diagnosed patients achievecomplete remission with first-line therapy, but prognosisworsens for relapsed disease in both...
Eligibility Criteria
Inclusion
- ≥18 years old.
- Confirmed diagnosis of r/r AML
- CLL1 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:
- Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL/min;
- Total bilirubin (TBIL) ≤ 2 x the ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- Females of childbearing potential must have a negative serum pregnancy test.
- Donor specific antibody (DSA) is negative: MFI \<= 2000.
- Provision of signed and dated informed consent form (ICF).
Exclusion
- Allergic to drug used in this study.
- Subjects received any antitumor therapy as follows, prior to first NK infusion:
- Systemic steroid therapy within 3 days (except physiological replacement therapy);
- Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less;
- Radiotherapy within 4 weeks;
- Donor lymphocyte infusion within 6 weeks;
- Intrathecal treatment within 1 week;
- CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;
- History of allogeneic stem cell transplantation.
- Received the vaccine within 4 weeks prior to the first infusion and/or expected to require vaccination from the study period to 12 weeks after the last infusion.
- Active central nervous system Leukemia.
- Acute Promyelocytic Leukemia (APL).
- History of other malignant tumors, except for those who have achieved complete remission more than 5 years after radical treatment without any signs of recurrence.
- Active autoimmune diseases.
- History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc.
- Serious cardiovascular and cerebrovascular diseases:
- Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to first infusion;
- New York Heart Association (NYHA) class II or above congestive heart failure or left ventricular ejection fraction (LVEF) \<50% in color Doppler echocardiography;
- Hypertension that cannot be controlled by drug.
- Active pulmonary infection; SpO2 ≤90%; Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease.
- Uncontrolled bacterial, fungal, or viral infection. Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection.
- History of substance abuse.
- Toxicity induced by previous therapy not recovered to ≤ grade 2(NCI-CTCAE v5.0).
- Large surgical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.
- Pregnant/breastfeeding women.
- Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject.
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06027853
Start Date
September 10 2023
End Date
August 31 2026
Last Update
September 7 2023
Active Locations (1)
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1
Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University
Hangzhou, Zhejiang, China