NCT06367673 Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia
| NCT ID | NCT06367673 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhejiang University |
| Condition | AML, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-04-30 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML
Eligibility Criteria
Inclusion Criteria: * ≥18 years old. * Confirmed diagnosis of r/r AML * CLL1 or CD33 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: 1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL/min; 2. Total bilirubin (TBIL) ≤ 2 x the ULN; 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; 4. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN 6.Females of childbearing potential must have a negative serum pregnancy test. 7.Donor specific antibody (DSA) is negative: MFI \<= 2000. 8.Provision of signed and dated informed consent form (ICF). Exclusion Criteria: * Allergic to drug used in this study. * Subjects received any antitumor therapy as follows, prior to first NK infusion: a. Systemic steroid therapy within 3 days (except physiological replacement therapy):b. Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less; c. Radiotherapy within 4 weeks; d. Donor lmphocyte infusion within 6 weeks: e. Intrathecal treatment within 1 week; f 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 pror to the first infusion andor expected to reuire vaccination from the study period to 12 weeks ater the last intusion * Active central nervous system Leukemia. * Acute Promyelocytic Leukemia (APL). .History of other malicnant tumors, except for those who have achieved omplete remission more than 5 years after radical treatment without any sions of recurence9. History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc * Active autoimmune diseases. * Serious cardiovascular and cerebrovascular diseases:a. Severe heart rhythm or conduction abnormalities, corrected OT interval (OTc)\>480 ms:h, Aute coronay sndrome conestve heat faur. aortic disection-stroke. or other orade 3 or hioher ardiovasular and cerebrovascular events within 6 months orior to firstinfusiorC, New York Heart Association (NYHA) class l or above congestive heart failure or left ventricular eiection fraction (LVEF \<50% in olor Doppler echocardiography,d. Hypertension that cannot be controlled by drug. * Active pulmonary infection: Sp02 90%: Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease * Uncontrolled bacterial, fungal, or viral infection.Known HlV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection * Historv of substance abuse. * Toxicity induced by previous therapy not recovered to s grade 2(NCI-CTCAE 5.0).15. Large suraical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.16. Pregnant/breastfeeding women.17. nvestigator-assessed presence of any medical or social issue that are likely to interfere with study conduct or may cause increased risk to subiect
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT06367673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06367673 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06367673 currently recruiting?
Yes, NCT06367673 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06367673 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06367673 clinical trial?
NCT06367673 is sponsored by Zhejiang University. The principal investigator is He Huang, MD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 24 participants.