HD CD19 CAR-T (Huadao)

Phase I: Main objective: Main objective: To evaluate the safety and tolerability of HD CD19 CAR-T cells in the treatment of r/r B-ALL patients and determine the MTD or RP2D. Secondary objectives and endpoints: 1) Evaluate the pharmacokinetic (PK) characteristics of HD CD19 CAR-T cells in vivo 2) Preliminary evaluation of the effectiveness of HD CD19 CAR-T cells in the treatment of r/r B-ALL Exploratory objectives: 1) Exploratory study of the immunogenicity of HD CD19 CAR-T 2) Exploratory study of the pharmacodynamic (PD) characteristics of HD CD19 CAR-T cells in vivo Phase II: Main objective: Main objective: To further confirm the effectiveness of HD CD19 CAR-T cells in the treatment of adult r/r B-ALL patients. Secondary objectives: To evaluate the safety and efficacy, pharmacokinetic and pharmacodynamic characteristics of HD CD19 CAR-T. Exploratory objectives 1) Exploratory analysis of the correlation between baseline and CAR-T efficacy, safety, and PK. 2) Exploratory analysis of CAR structural genome insertion sites.