JY509 Universal NK Cell Injection for the Treatment of Relapsed/Refractory Pediatric B-ALL

February 5, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

JY509 Universal NK Cell Injection for the Treatment of Relapsed or Refractory Pediatric B-cell Acute Lymphoblastic Leukemia

This is a single-arm, open-label, dose-escalation and expansion, prospective clinical trial conducted in patients with relapsed or refractory pediatric B-cell acute lymphoblastic leukemia to evaluate the safety and efficacy of JY509 universal NK cell injection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically diagnosed as relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), and meeting any of the following criteria:①The patient fails to achieve bone marrow complete remission (MRD > 1%) after at least 2 courses of standard induction chemotherapy; or those with pre-treatment specific molecular markers/immunophenotypes do not achieve molecular/immunological complete remission (remain non-negative post-treatment);②Relapse during chemotherapy, early relapse within 12 months after treatment discontinuation, or late relapse ≥ 12 months after complete remission, with failure to achieve complete remission (MRD > 1%) following 1 course of standard induction chemotherapy;③Relapsed after hematopoietic stem cell transplantation (HSCT);④Isolated bone marrow relapse, isolated extramedullary relapse (testicular leukemia, central nervous system leukemia), or combined relapse;
  • Tumor cells confirmed positive for CD19 by flow cytometry (FCM) or immunohistochemistry (IHC);
  • Expected survival ≥ 3 months from the date of signing the informed consent form (ICF);
  • Aged 3-18 years (inclusive), no gender restriction;
  • ECOG ≤ 2;
  • HGB ≥ 70 g/L, PLT ≥ 50×10⁹/L (recombinant human erythropoietin or blood transfusion permitted);
  • Liver and kidney functions, as well as cardiopulmonary functions, shall meet the following requirements:①LVEF≥50%;②Oxygen saturation ≥ 90%;③Total bilirubin ≤3×ULN;④ALT/AST<3×ULN;⑤Serum creatinine≤2×ULN.If organ dysfunction links to the disease, investigator evaluates enrollment;
  • The subject or guardian understands and signs the informed consent form.

Exclusion Criteria:

  • Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.
  • Complicated with other progressive malignant tumors.
  • Presence of active and/or uncontrolled infections that have not been effectively managed.
  • Complicated with severe autoimmune diseases or congenital immunodeficiency.
  • Subjects to be excluded if: testing positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening, with peripheral blood hepatitis B virus (HBV) DNA levels above the lower limit of detection; testing positive for hepatitis C virus (HCV) antibody, with positive peripheral blood HCV RNA; testing positive for human immunodeficiency virus (HIV) antibody; testing positive for Treponema pallidum particle agglutination assay (TPPA).
  • A history of severe hypersensitivity to biological products (including antibiotics).
  • Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.
  • Unstable systemic diseases as judged by the investigator, including but not limited to severe hepatic, renal or metabolic diseases requiring drug therapy.
  • Having received major surgery assessed by the investigator as unsuitable for enrollment within 4 weeks prior to screening.
  • Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JY509 universal NK cell injection
Biological: JY509 universal NK cell injection
3+3 dose escalation trial and dose expansion trial

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The occurrence frequency, number of cases,incidence rate and severity of adverse events and adverse reactions occurring after infusion and before withdrawal or the safety follow-up period.
Time Frame: From enrolment to one year after infusion
From enrolment to one year after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2025137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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