B-Cell Lymphoma Clinical Trials

⁃ Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial procedures as required in the protocol;

⁃ Patients with relapsed/refractory (R/R) B-cell lymphoma/leukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO 2016 classification criteria, who have experienced disease progression under standard treatment regimens, are intolerant to standard treatment regimens, or lack effective standard treatment options;

⁃ Must meet the following criteria for R/R B-cell malignant tumors:

∙ (1) B-cell tumors include 3 categories:

• B-cell acute lymphoblastic leukemia (B-ALL);

• ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.;

• ③ Aggressive B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), mantle cell lymphoma (MCL); (2) R/R B-ALL (meeting any 1 of the 4 criteria below):

• Relapse within 6 months after the first complete response (CR);

‣ Primary refractory patients who failed to achieve CR after 2 cycles of standard chemotherapy;

∙ Failure to achieve CR or relapse after first-line or multi-line salvage chemotherapy; ④ Relapse after hematopoietic stem cell transplantation (HSCT); (3) R/R B-cell lymphoma (meeting any 1 of the first 4 criteria below plus criterion 5):

• Tumor reduction \< 50% or disease progression after 4 courses of standardized chemotherapy per standard regimens;

‣ Relapse within 6 months after achieving CR with standard chemotherapy;

∙ ≥ 2 relapses after CR;

• Relapse after HSCT; ⑤ Adequate prior treatment received, including at least anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy regimens; 4. Aged 18-85 years (inclusive), male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6. Expected survival \> 14 days from the date of signing the informed consent form; 7. Hemoglobin (HGB) ≥ 60 g/L (transfusion allowed); 8. Absolute neutrophil count (ANC) ≥ 1,000/μl and platelet count ≥ 45,000/μl in peripheral blood (transfusion allowed); 9. Hepatic, renal, cardiac, and pulmonary functions meeting the following requirements:

‣ Total Bilirubin (TBIL) ≤ 1.5 × Upper Limits of Normal (ULN), excluding subjects with Gilbert's syndrome;

⁃ Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN;

⁃ Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance Rate (CCr) ≥ 60 mL/min (CCr estimated by the Cockcroft-Gault formula);

⁃ Left Ventricular Ejection Fraction (LVEF) ≥ 50%; echocardiogram (ECHO) confirms no clinically significant severe pericardial effusion or severe arrhythmia;

⁃ Baseline transcutaneous oxygen saturation \> 90% under room air;

⁃ No clinically significant severe pleural effusion; 10. Subjects with pregnancy plans must agree to use contraceptive measures from before study enrollment until 6 months after the end of the study;