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 12-75 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: 1. 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; 2. Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line / multi-line salvage chemotherapy; 3. Relapse after autologous or allogeneic hematopoietic stem cell transplantation; 4. 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): 1. Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN); 2. Grass aminotransferase (AST) ≤3 times ULN; 3. Total bilirubin ≤1.5 times ULN; 4. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min; 5. Indoor oxygen saturation ≥ 92%; 6. Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings; 7. There is no clinically significant pleural effusion; 11. Adequate bone marrow reserve without transfusion, defined as: 1. Absolute neutrophil count (ANC)\>1.000 / mm3; 2. Absolute lymphocyte count (ALC)≥ 300 / mm3; 3. Platelet≥50.000/mm3; 4. Hemoglobin\>8.0 g/dl; 12. Subjects using the following drugs need to meet the following conditions: 1. Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed; 2. Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment; 3. Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion; 4. Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody; 5. 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. Exclusion Criteria: 1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia; 2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement; 3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period; 4. Patients who have previously received any anti-CD19 / anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors); 5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors); 6. Subjects with radiation therapy within 2 weeks prior to the infusion; 7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\> 500 IU / mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive; 8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion); 9. Subjects with unstable angina pectoris and / or myocardial infarction within the 6 months prior to screening; 10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions: 1. Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study); 2. Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study; 3. The primary malignancy has been completely removed and is in complete remission for 5 years. 11. Arrhythmic subjects without medical management control; 12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion; 13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis); 14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion; 15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and / or clinical criteria. 16. Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.