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Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06027853•Zhejiang University

View on ClinicalTrials.gov

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

Detailed Description

Acute myelogenous leukemia (AML) is a potentially cur-able disease; 70% of newly diagnosed patients achievecomplete remission with first-line therapy, but prognosisworsens for relapsed disease in both pediatric and adultpatients. CLL-1 has attracted the researchers' attention due to its high expression in AML while being absent in normal hematopoietic stem cell. Accumulating evidence have demonstrated CLL-1 is an ideal target for AML.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years old.
•2. Confirmed diagnosis of r/r AML
•3. CLL1 expression is positive in AML blasts.
•4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
•5. 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.
+2 more criteria

Exclusion Criteria

•1. Allergic to drug used in this study.
•2. Subjects received any antitumor therapy as follows, prior to first NK infusion:
•1. Systemic steroid therapy within 3 days (except physiological replacement therapy);
•2. Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less;
•3. Radiotherapy within 4 weeks;
•4. Donor lymphocyte infusion within 6 weeks;
•5. Intrathecal treatment within 1 week;
•6. CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;
•3. History of allogeneic stem cell transplantation.
•4. 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.
+17 more criteria

Locations (1)

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

Hangzhou, Zhejiang, China

Key Dates

Start Date

September 10, 2023

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

September 7, 2023

Enrollment

ESTIMATED participants

Conditions

AML, Adult

Interventions

CLL1 CAR-NK cell injection

DRUG

Contacts

He Huang, MD

CONTACT

+8613605714822 hehuangyu@126.com

Yongxian Hu, MD

CONTACT

+8615957162012 huyongxian2000@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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