Tests JD123 cell therapy in adults with relapsed or refractory acute myeloid leukemia
Tests JD123, off-the-shelf CAR-NK cells, in adults with returning or resistant acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Off-the-shelf CD123 CAR-NK for R/R AML
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) that is CD123-positive and has come back or did not respond to treatment. It tests a new CAR-NK cell treatment, JD123 injection.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- CD123-positive AML that has relapsed or is refractory, confirmed by bone marrow biopsy, immunohistochemistry or flow cytometry. People who only have minimal residual disease (MRD) can also join.
- Earlier treatment
- Relapsed or refractory disease as defined in the record, for example no response after 2 courses of standard treatment, or relapse after allogeneic stem cell transplantation (allo-HSCT). No systemic hormones within 4 weeks before enrolment (inhaled corticosteroids are allowed).
- Biomarker or test result
- CD123-positive leukemia cells
Main reasons for not taking part
- Active leukemia in the central nervous system
- Active infection needing intravenous treatment, including HBV, HCV, HIV, syphilis or active tuberculosis
- Pregnant or breastfeeding women
- Serious autoimmune disease or immunodeficiency disease
- Known contraindication to the fludarabine/cyclophosphamide chemotherapy given before treatment
Read by machine on 12 November 2026.
Where in China
- Peking University People's HospitalBeijing, ChinaContact: Meng Lv, MD PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06201247
- Record updated
- 11 March 2025
- Original description
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).Read full original descriptionShow less
Safety and Efficacy of Universal Off-the-shelf CAR-NK Cells Targeted CD123 (JD123 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).
Inclusion: Age ≥ 18 years old, no gender or race; Expected survival period ≥ 3 months; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria:; 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; Patients relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT) C. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment; Adequate organ function:; 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: Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); 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; History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness; Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions; -; Active Central nervous system leukemia; Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; Women who are pregnant (urine/blood pregnancy test positive) or lactating.