B-cell Acute Lymphoblastic Leukemia (B-ALL)
Conditions
Brief 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)
Interventions
BIOLOGICALJY231
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)
Sponsors
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
1. up to 75 years (Child, Adult) , either sex； 2. 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. 3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19); 4. According to the researcher's assessment, the expected survival period is greater than 3 months; 5. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 3; 6. 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%; 7. 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; 8. MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia; 9. Individuals with fertility must agree to the use of efficient contraceptive methods; 10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.
Exclusion criteria
1. Pregnant or lactating women, as well as women with pregnancy plans within six months; 2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive; 3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity); 4. Previously received treatment targeting CD19; 5. Received autologous hematopoietic stem cell transplantation within 6 weeks; 6. The presence of uncontrollable active bacterial or fungal infections; 7. Allergies to research related drugs or cellular components; 8. Active autoimmune diseases exist; 9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present; 10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation; 11. Received other experimental drug treatments within the past 3 months; 12. Existence of grade II-IV acute graft versus-host disease (GVHD) or widespread chronic GVHD; 13. Researchers believe that other reasons are not suitable for clinical trial participants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Related adverse events (AEs) | Up to 12 months after infusion | The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. |
| MTD | Up to 28 days after infusion | MTD will be determined based on DLTs observed during the first 28 days of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of remission (DOR) | Up to 2 years after infusion | Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD. |
| Time To Progression (TTP) | Up to 2 years after infusion | The duration from the initiation of treatment until the first occurrence of objective disease progression. |
| Overall Response Rate (ORR) | At 2,4,8 and 12 weeks after infusion | Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission (CR) and complete remission with incomplete hematological recovery (CRi). |
| Overall survival (OS) | Up to 2 years after infusion | Overall survival (OS) is the time from randomization to death from any cause. |
| Progression-free survival (PFS) | Up to 2 years after infusion | 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. |
| Best Overall Response | Up to 24 weeks after infusion | The optimal degree of disease status improvement achieved by the patient over the course of the entire clinical trial or treatment period. |
Countries
China
Contacts
Primary ContactSanbin Wang, Doctor
Outcome results
None listed