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Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia | Clinical Trials | Clareo Health

UNKNOWNEARLY_PHASE1

Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

Early Clinical Study of Allogenic CD123-CAR-NK Cells (JD023 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia

NCT05574608•Affiliated Hospital to Academy of Military Medical Sciences

View on ClinicalTrials.gov

Summary

The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients.

Detailed Description

This is a study of allogenic CD123-CAR NK cells. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of CD123-CAR-NK cells. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years old, no gender or race;
•2. Expected survival period ≥ 3 months;
•3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
•4. The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met one of the following criteria:
•A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; C. Patients eligible for relapsed or refractory AML remained minimally residual disease positive after salvage therapy
•5. Adequate organ function:
•A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
•6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;
•7. Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

•1. Central nervous system involved;
•2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
•3. Systemic use of hormones within 2 weeks prior to enrollment (except for patients with inhaled corticosteroids);
•4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
•5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
•6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
•7. Women who are pregnant (urine/blood pregnancy test positive) or lactating;
•8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;
•10\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.

Locations (1)

The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

October 30, 2023

Completion Date

October 30, 2024

Last Updated

April 26, 2023

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia RefractoryAcute Myeloid Leukemia Recurrent

Interventions

CD123-CAR-NK cells

BIOLOGICAL

Contacts

Liangding Hu, Doctor

CONTACT

+86 01066947171 huliangding@sohu.com

Yao Sun, Doctor

CONTACT

+86 01066947172 suny320@126.com

Master Framework For Relapse or Refractory Acute Myeloid Leukemia

NCT06459024

Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory

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RECRUITINGPHASE2

CLAG-GO for Patients With Persistent, Relapsed or Refractory AML

NCT04050280

Acute Myeloid Leukemia, AdultAcute Myeloid Leukemia Recurrent+1 more

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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: April 26, 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.

View ClinicalTrials.gov Terms and Conditions

Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

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