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

Affiliated Hospital to Academy of Military Medical Sciences (Other)
Overall Status
Recruiting ID
Beijing JD Biotech Co. LTD. (Other)

Study Details

Study Description

Brief 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 and maximum tolerated dose of CD123-CAR NK cells given to these patients.

Condition or Disease Intervention/Treatment Phase
  • Biological: CD123-CAR-NK cells
Early Phase 1

Detailed Description

This is a dose-escalation 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.

Study Design

Study Type:
Anticipated Enrollment :
12 participants
Intervention Model:
Sequential Assignment
Intervention Model Description:
Evaluate the safety of JD023 injection, including dose-limiting toxicity (DLT) and adverse events (AE), etc.Evaluate the safety of JD023 injection, including dose-limiting toxicity (DLT) and adverse events (AE), etc.
None (Open Label)
Primary Purpose:
Official Title:
Early Clinical Study of Allogenic CD123-CAR-NK Cells (JD023 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Experimental: CD123-CAR-NK.

The relapsed/refractory AML patients will receive allogenic CD123-Targeted CAR-NK cells infusion up to 3 dose levels (1x10^6/kg, 5x10^6/kg, 2x10^7/kg) after FC chemotherapy.

Biological: CD123-CAR-NK cells
CD123-CAR-NK is an allogenic CD123-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.

Outcome Measures

Primary Outcome Measures

  1. Dose limiting toxicities (DLTs) [1 Months]

  2. Treatment-emergent adverse events [3 months]

  3. Treatment-related adverse events [3 months]

Secondary Outcome Measures

  1. Complete response (CR) [3 months]

  2. Progression free survival (PFS) [12 months]

  3. Overall Survival (OS) [12 months]

  4. Proportion of subjects with minimal-residual disease (MRD) negative response [3 months]

  5. The area under the concentration time-curve (AUC) of CD123-CAR-NK cells [3 Months]

  6. Peak levels of CD123-CAR-NK cells (maximum concentration or Cmax) [3 Months]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts 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 the following criteria:

  1. 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;
  1. Adequate organ function:
  1. 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%;
  1. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;

  2. 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 4 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;

  9. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.

Contacts and Locations


Site City State Country Postal Code
1 The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital Beijing Beijing China 100071

Sponsors and Collaborators

  • Affiliated Hospital to Academy of Military Medical Sciences
  • Beijing JD Biotech Co. LTD.


  • Principal Investigator: Liangding Hu, Docotr, The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Affiliated Hospital to Academy of Military Medical Sciences Identifier:
Other Study ID Numbers:
  • CAR-NK123-JD
First Posted:
Oct 10, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022