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New treatment option for AML, Adult
Official title Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06027853
What this study is testing
What is CLL1 CAR-NK cell injection?
CLL1 CAR-NK cell injection is an investigational medicine, being studied as a potential treatment for aml, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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:
You likely can't join if
- Allergic to drug used in this study.
- people 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;
See the full eligibility criteria
- ≥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).
- Allergic to drug used in this study.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.