RecruitingPhase 1NCT06027853

Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia

Clinical Study to Evaluate the Safety and Efficacy of iPSC NK Cells Targeting CLL1 in Patients With Relapsed/Refractory AML


Sponsor

Zhejiang University

Enrollment

24 participants

Start Date

Sep 10, 2023

Study Type

INTERVENTIONAL

Conditions

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/refractory AML


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment using donor Natural Killer (NK) immune cells engineered to target a protein called CLL1, which is found on the surface of leukemia cells in acute myeloid leukemia (AML). AML is a fast-growing cancer of the blood and bone marrow. This is a cell therapy approach — using donor immune cells to attack the cancer. **You may be eligible if...** - You are 18 or older with relapsed or treatment-resistant AML - Your AML cells test positive for the CLL1 protein - Your overall health and organ function (heart, kidneys, liver) are adequate **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL, a specific subtype) - You have active leukemia in the central nervous system (brain/spinal fluid) - You have HIV, active hepatitis B or C - You have had a prior stem cell transplant - You have had recent heart problems, uncontrolled blood pressure, or lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCLL1 CAR-NK cell injection

Drug: CLL1 NK cell therapy Drug: Cyclophosphamid Lympho-conditioning Agent Drug: Fludarabine Lympho-conditioning Agent Drug: VP-16 Lympho-conditioning Agent


Locations(1)

Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University

Hangzhou, Zhejiang, China

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NCT06027853


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