B-cell Acute Lymphoblastic Leukemia (B-ALL)Early Phase 1NCT06514768
JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)
A Early Phase 1 study testing JY231 in people with B-cell Acute Lymphoblastic Leukemia (B-ALL), run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
Trial summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL) Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia (B-ALL)
- What is being tested?
- JY231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 30 Jun 2026
- Phase
- Early Phase 1
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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- up to 75 years (Child, Adult) , either sex；
- Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is >5%, or the bone marrow MRD analysis comfirmed as B-ALL.
- Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19);
- According to the researcher's assessment, the expected survival period is greater than 3 months;
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 3;
- The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin < 34 μ Mol/L; Creatinine clearance rate>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%;
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- Peripheral blood lymphocyte absolute count: absolute lymphocyte count (ALC) ≥ 0.5E9/L, blood platelet (PLT) > 30E9/L, Hb > 80g/L, with a single venous access and no other contraindications for blood cell separation;
- MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;
- Individuals with fertility must agree to the use of efficient contraceptive methods;
- The subject or their legal guardian can understand and voluntarily sign a written informed consent form.
Who cannot join
- Pregnant or lactating women, as well as women with pregnancy plans within six months;
- Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
- Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
- Previously received treatment targeting CD19;
- Received autologous hematopoietic stem cell transplantation within 6 weeks;
- The presence of uncontrollable active bacterial or fungal infections;
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- Allergies to research related drugs or cellular components;
- Active autoimmune diseases exist;
- Patients with unstable or active ulcers or gastrointestinal bleeding currently present;
- Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
- Received other experimental drug treatments within the past 3 months;
- Existence of grade II-IV acute graft versus-host disease (GVHD) or widespread chronic GVHD;
- Researchers believe that other reasons are not suitable for clinical trial participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)
- Being tested
- JY231
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY231Biological
Infusion of JY231 Injection by dose of 1-10×10^6 Transduction Units (TU)/kg、1-5×10^7 TU/kg、5-10 ×10^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)
| Study group | Role | What they receive |
|---|---|---|
| JY231 injection for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) | Experimental | Not described Receives: Biological: JY231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Up to 12 months after infusion
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Measured: Up to 28 days after infusion
Secondary outcomes (6)
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
Measured: At 2,4,8 and 12 weeks after infusion
Best Overall Response
The optimal degree of disease status improvement achieved by the patient over the course of the entire clinical trial or treatment period.
Measured: Up to 24 weeks after infusion
Duration of remission (DOR)
Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD.
Measured: Up to 2 years after infusion
Time To Progression (TTP)
The duration from the initiation of treatment until the first occurrence of objective disease progression.
Measured: Up to 2 years after infusion
Progression-free survival (PFS)
Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause.
Measured: Up to 2 years after infusion
Overall survival (OS)
Overall survival (OS) is the time from randomization to death from any cause.
Measured: Up to 2 years after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start20 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic Leukemia (B-ALL)Studies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514768
- Sponsor's protocol ID
- JY-CT-23-006
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No