Relapsed/Refractory Pediatric B-ALLEarly Phase 1NCT07406178
JY509 Universal NK Cell Injection for the Treatment of Relapsed/Refractory Pediatric B-ALL
A Early Phase 1 study testing JY509 universal NK cell injection in people with Relapsed/Refractory Pediatric B-ALL, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Relapsed/Refractory Pediatric B-ALL
- What is being tested?
- JY509 universal NK cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 Apr 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: 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.
- Conditions
- Relapsed/Refractory Pediatric B-ALL
- Being tested
- JY509 universal NK cell injection
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY509 universal NK cell injectionBiological
3+3 dose escalation trial and dose expansion trial
| Study group | Role | What they receive |
|---|---|---|
| JY509 universal NK cell injection | Experimental | Not described Receives: Biological: JY509 universal NK cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to one year after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start20 Jan 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Pediatric B-ALLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406178
- Sponsor's protocol ID
- IIT2025137
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JY509 Universal NK Cell Injection for the Treatment of Relapsed or Refractory Pediatric B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07406178
- Acronym / sponsor ID
- IIT2025137
- Conditions
- Relapsed/Refractory Pediatric B-ALL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JY509 universal NK cell injection | Experimental | Biological: JY509 universal NK cell injection |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JY509 universal NK cell injection3+3 dose escalation trial and dose expansion trial | Biological | JY509 universal NK cell injection |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JY509 universal NK cell injection in people with Relapsed/Refractory Pediatric B-ALL, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.