Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection

Inclusion criteria

• 1. Age range of 18-70 years old, gender not limited;
• 2. Expected survival time exceeds 12 weeks;
• 3. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines and meeting the corresponding frontline treatment line requirements;
• 4. There are assessable lesions (applicable only to lymphoma patients);
• 5. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point;
• 6. The main organ functions well and the relevant examination indicators meet the corresponding requirements;
• 7. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;
• 8. Those who can understand this experiment and have signed the informed consent form.

Exclusion criteria

• 1. Accompanied by other uncontrolled malignant tumors;
• 2. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy;
• 3. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;
• 4. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;
• 5. Participants with atrial or ventricular involvement;
• 6. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;
• 7. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;
• 8. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;
• 9. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
• 10. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;
• 11. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections);
• 12. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.