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New treatment option for Relapsed Adult AML
Official title CLL-1 CAR-NK Cells for Relapsed/Refractory AML
ClinicalTrials.gov ID: NCT06307054
What this study is testing
What is anti-CLL-1 CAR NK cells?
anti-CLL-1 CAR NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed adult aml.
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 study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia.
- 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 to 70
You may be able to join if
- Age 18-70 years, gender unrestricted;
- Expected survival time exceeds 12 weeks;
- ECOG score 0-2;
- Meets the 2022 WHO criteria for acute myeloid leukemia and flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry...
- Relapse criteria: Bone marrow shows primitive cells ≥5% after hematological remission (excluding post-chemotherapy hematopoietic recovery); or at...
You likely can't join if
- Any of the following conditions disqualify a subject from participation in the trial:
- Confirmed AML with PML-RARA fusion gene;
- History of malignancies other than acute myeloid leukemia within 5 years before screening, except adequately treated carcinoma in situ of the cervix...
- Uncontrolled active bacterial, viral, or fungal infections requiring treatment; HBsAg or HBcAb positive, with peripheral blood HBV DNA ≥ lower limit...
- Significant organ (cardiovascular, pulmonary) dysfunction; active gastrointestinal bleeding within the past 3 months; uncontrolled hypertension or...
- Any uncontrolled active disease that hinders participation in the trial;
See the full eligibility criteria
- Age 18-70 years, gender unrestricted;
- Expected survival time exceeds 12 weeks;
- ECOG score 0-2;
- Meets the 2022 WHO criteria for acute myeloid leukemia and flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry shows CLL1 expression ≥50% and meets the following criteria for relapse...
- Relapse criteria: Bone marrow shows primitive cells ≥5% after hematological remission (excluding post-chemotherapy hematopoietic recovery); or at least two peripheral blood samples taken at least one week apart show...
- Refractory criteria: No complete remission after two courses of standard intensive chemotherapy based on the 3+7 regimen, and no complete remission after second-line salvage chemotherapy or treatment including targeted...
- Able to establish the required venous access for collection, and no contraindications for leukapheresis;
- Liver and kidney function, cardiac and pulmonary function meet the following requirements:
- Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min or creatinine ≤ 2.5×ULN;
- Ejection fraction \>50%, no clinically significant electrocardiogram changes; baseline blood oxygen saturation \>92%; total bilirubin ≤ 3×ULN; ALT and AST ≤ 3×ULN;
- Able to understand and sign the informed consent form.
- Any of the following conditions disqualify a subject from participation in the trial:
- Confirmed AML with PML-RARA fusion gene;
- History of malignancies other than acute myeloid leukemia within 5 years before screening, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin, or...
- Uncontrolled active bacterial, viral, or fungal infections requiring treatment; HBsAg or HBcAb positive, with peripheral blood HBV DNA ≥ lower limit of detection; HCV RNA positive in the presence of hepatitis C virus...
- Significant organ (cardiovascular, pulmonary) dysfunction; active gastrointestinal bleeding within the past 3 months; uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy...
- Any uncontrolled active disease that hinders participation in the trial;
- Active, uncontrolled central nervous system involvement, or a history of central nervous system disease requiring treatment (such as epilepsy);
- people receiving systemic corticosteroid therapy before screening and deemed by the investigator to require long-term systemic corticosteroid therapy during the study period (excluding inhalation or local use); and...
- people who have used PD-1 or PD-L1 monoclonal antibodies within 3 months before enrollment
- Pregnant or lactating women; and people planning to become pregnant within 1 year after infusion, during or after the treatment period;
- Uncontrolled active infections (excluding simple urinary tract infections or upper respiratory tract infections);
- people who have received CAR-T therapy or other gene-modified cell therapy in the past;
- Patients after allogeneic transplantation, with no significant acute or chronic GVHD, and have discontinued immunosuppressive drugs for at least 1 month;
- Known allergy to any component of anti-CLL-1 CAR-NK cell infusion or chemotherapy regimen (cyclophosphamide and fludarabine);
- Any situation deemed by the investigator to compromise the safety of the subject or interfere with the purpose of the study, or deemed unsuitable for participation by the investigator;
- Afflicted with a condition that affects the ability to sign the informed consent form in writing or to comply with the study procedures; unwilling or unable to comply with the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.