Autologous Bedside CD19 CAR T-cell Therapy for B-ALL

Inclusion Criteria: * Age 18 to 70 years inclusive at the time of signing informed consent. * Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria. * CD19 expression confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator. * Life expectancy ≥12 weeks in the opinion of the investigator. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Adequate organ function as demonstrated by the most recent assessment during the screening period, defined as: * Creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN) * Total bilirubin ≤1.5 × ULN (for patients with documented Gilbert's syndrome, total bilirubin ≤2.5 × ULN is acceptable) * For women of childbearing potential (WOCBP), a negative serum pregnancy test must be documented within 7 days prior to enrollment. WOCBP and male patients with partners who are WOCBP must agree to use highly effective …