Recent advances in multi-agent chemotherapy have improved outcomes for pediatric and adolescent patients with B-cell acute lymphoblastic leukemia (B-ALL). However, patients with relapsed or refractory (r/r) disease continue to face limited treatment options and poor prognosis [1].

On November 7, 2025, Puzolcabtagene Autoleucel was approved by the NMPA for pediatric and adolescent patients with B-ALL, and the first post-approval dose was prescribed on the same day by Prof. Yi Hai at the General Hospital of Western Theater Command. The patient has now completed one month of follow-up after CAR-T infusion, with initial clinical outcomes available.

According to clinical records, leukapheresis was completed on November 11, 2025. The patient received lymphodepleting conditioning with fludarabine and cyclophosphamide (FC regimen) on November 29, followed by infusion of Puzolcabtagene Autoleucel Injection on December 4.Following CAR-T infusion, CAR-T cells demonstrated in vivo expansion. Peripheral blood CAR⁺ cell levels were 4.04 cells/μL on Day 7 and reached a peak of 1,638.80 cells/μL on Day 10, indicating active proliferation.

Target engagement was also observed. Peripheral CD19⁺ B cells remained at 0% from Day 7 to Day 14, indicating sustained depletion of CD19-positive B cells.Bone marrow assessment showed that the patient achieved MRD-negative status. Flow cytometry analyses at Day 14 and Day 28 detected no abnormal B-lineage blasts, consistent with a deep response.