RecruitingPhase 1NCT06307054

CLL-1 CAR-NK Cells for Relapsed/Refractory AML

The Safety and Efficacy for Anti-human CLL-1 CAR-NK Cells in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

24 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Refractory AML Relapsed Adult AML

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cell therapy — engineered natural killer (NK) cells designed to target a protein called CLL-1 on leukemia cells — for people with acute myeloid leukemia (AML) that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with AML and your leukemia cells express the CLL-1 protein (at least 70% by flow cytometry) - Your cancer has relapsed (come back) or is refractory (has not responded to standard chemotherapy) - Your general health is adequate (ECOG 0–2) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your leukemia does not express CLL-1 - Your general health or organ function is too poor to tolerate the treatment - You do not meet the relapse or refractory criteria 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

DRUGanti-CLL-1 CAR NK cells

Eligible patients enrolled in the study after screening will receive lymphocyte collection(from the patient or a donor ) and receive single dose CLL-1 CAR NK cells infusion after a successful cell production. There are a total of four cell dose level:5×10\^6 CAR-NK cells/kg,1×10\^7CAR-NK cells/kg,2×10\^7CAR-NK cells/kg,4×10\^7CAR-NK cells/kg

Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06307054

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