Non-Interventional Study of Puzol-cel for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Objective response rate includes CR, CRi

MRD-negative ORR within 2 years by flow cytometry as assessed by investigator.

Best overall response means the proportion of patients with the best efficacy (CR or CRi) after Puzol-cel therapy.

Overall survival means the time from infusion of Puzol-cel to death of subjects from any cause

Duration of response means the time from first assessment of CR or CRi to first assessment of disease recurrence or death from any cause, whichever occurs first

Relapse free survival means time from subject infusion of Puzol-cel to first disease relapse or death from any cause (whichever occurs first)

Event free survival means the time from the infusion of Puzol-cel to the time of the following events (whichever occurs first): a. Death from any cause after remission; b. Disease recurrence; c. Withdrawal from the clinical trial after treatment failure or meeting the withdrawal criteria.

Number of participants with adverse events as assessed by CTCAE v5.0

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Number of participants with special interest adverse events as assessed by CTCAE v5.0,The following adverse events were defined as adverse events of special interest for this study: a.Cytokine release syndrome (CRS) of grade 3 and above; b. Immune effector cell-associated neurotoxicity syndrome (ICANS) of grade 3 and above; c.Grade 3 and above infection; d.Grade 3 and above acute tumor lysis syndrome; e.Unresolved cytopenias lasting 28 days.

RCL Detection: the incidence of Replication Competent Lentivirus.

investigator-assessed ORR, including CR and CRi; investigator-assessed ORR with MRD-negative, including CR and CRi.

The subject's height were measured before infusion and 1, 2, 3 months after infusion and every three months thereafter.