Exploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia

Exclusion criteria

• . Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation (meeting any of the following), who are planned to receive allogeneic hematopoietic stem cell transplantation or CD19/CD3 bispecific antibody (blinatumomab) therapy and refuse CAR-T cell immunotherapy as consolidation treatment, including any of the following conditions:
• . Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.
• . Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.
• . Non-disease-related hepatic or renal dysfunction defined as:
• . History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.
• . Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled diabetes, severe gastrointestinal disease, severe cardiopulmonary disease, autoimmune disease, immunodeficiency, or uncontrolled infections.
• . History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.
• . Pregnant or breastfeeding women.