JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Leukemia

Prior treatment

• Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;
• Subjects who have had radiation therapy within 2 weeks prior to infusion;
• Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);
• Subjects with unstable angina and/or myocardial infarction within 6 months prior to Screening;
• Subjects with other prior or concurrent malignancies, with the following exceptions:
  • ① Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);
  • ② Cancer in situ of the cervix or breast that has been curatively treated and shows no signs of recurrence for at least 3 years prior to study entry;
  • ③ primary malignancy that has been completely resected and in complete remission for ≥ 5 years.

Other illness

• Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
• Presence of subjects with arrhythmias not controlled by medical management;
• Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis);
• Subjects who, in the investigator's judgment and/or clinical criteria, have a contraindication to any of the investigational procedures or have other medical conditions that may place them at unacceptable risk.
• Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance.

Other

• Subjects with active central nervous system (CNS) leukemia;
• Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;

• Age 18\~75 years old, gender is not limited;
• Patients with a diagnosis of Cluster of Differentiation 19 positive(CD19+) B-ALL confirmed by flow cytometry or immunohistochemistry according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
• Meet the diagnosis of relapsed/refractory (relapsed/refractory) r/r CD19+ B-ALL, including any of the following:
  • A.relapse within 12 months of first remission; B.initial refractory treatment that does not achieve complete remission after two doses of standard chemotherapy, or complete remission or relapse after first-line or multiple lines of salvage therapy;
  • C.Patients with Ph+-ALL (Philadelphia chromosome-positive) in whom relapse or refractory is defined as meeting any of the following:
  • ① Relapse or refractory after treatment with at least two tyrosine kinase inhibitor (TKI) agents or intolerance to TKI-type agents;
  • ② Resistance or failure to achieve remission after receiving second-line TKI therapy;
  • ③ Not suitable for TKI therapy;
• Bone marrow cytomorphology with \>5% prolymphocytes + juvenile lymphocytes; or flow Minimal Residual Disease(MRD) \>=0.01%
• Serum total bilirubin ≤ 51 mol/L, serum alanine aminotransferase (ALT) and azelaic transaminase (AST) both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L, and platelets ≥ 20×109/L;
• Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
• Subjects without active pulmonary infection and inspiratory finger pulse oxygen saturation ≥92%;
• Subjects have not received radiotherapy, chemotherapy, monotherapy or other anti-ALL therapy within 1 week prior to screening;
• Predicted survival of 3 months or more;
• Eastern Cooperative Oncology Group(ECOG) score of 0-2;
• Subjects or their legal guardians volunteered to participate in this study and signed an informed consent form;