JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia

Inclusion Criteria

• •1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
• •2. Age is 18-75 years old and gender is not limited;
• •3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
• •4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:
• •* Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;
• •* Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line / multi-line salvage chemotherapy;
• •* Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.
• •5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\> 5%;
• •6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;
• •7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\> 15mm, or extranodal lesion of\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.
• •8. More than 12 weeks of expected survival period
• •9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;
• •10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):
• •* Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);
• •* Grass aminotransferase (AST) ≤3 times ULN;
• •* Total bilirubin ≤1.5 times ULN;
• •* Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min;
• •* Indoor oxygen saturation ≥ 92%;
• •* Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;
• •* There is no clinically significant pleural effusion;
• •11. Adequate bone marrow reserve without transfusion, defined as:
• •* Absolute neutrophil count (ANC)\>1.000 / mm3;
• •* Absolute lymphocyte count (ALC)≥ 300 / mm3;
• •* Platelet≥50.000/mm3;
• •* Hemoglobin\>8.0 g/dl;
• •12. Subjects using the following drugs need to meet the following conditions:
• •* Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;
• •* Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;
• •* Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;
• •* Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;
• •* CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).
• •13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.