A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

Required: CD19 overexpression (confirmed to express CD19 by flow cytometry)

The malignant cells in the bone marrow were confirmed to express CD19 by flow cytometry

Allowed: BCR fusion

For Ph+ALL patients, patients who have not achieved complete remission after receiving at least two Tyrosine kinase inhibitors (TKI) treatments or have relapsed after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment or have T315i mutation resistance to TKI drugs)

Must have received: standard induction chemotherapy — induction

early-stage refractory patients who failed to achieve complete remission after 2 courses of standard induction chemotherapy

Must have received: Tyrosine kinase inhibitor

For Ph+ALL patients, patients who have not achieved complete remission after receiving at least two Tyrosine kinase inhibitors (TKI) treatments or have relapsed after complete remission

Must have received: allogeneic hematopoietic stem cell transplantation

patients with recurrence after allogeneic hematopoietic stem cell transplantation

Cannot have received: CAR-T cell therapy

Those who have received CAR-T therapy or other gene-modified cell therapy before screening

Cannot have received: anti-CD19 drug

Received anti-CD19 drug treatment before screening

Cannot have received: chemotherapy, targeted therapy and other drug treatments

Exception: within 14 days or at least 5 half-lives (whichever is shorter)

Received chemotherapy, targeted therapy and other drug treatments within 14 days or at least 5 half-lives (whichever is shorter)

Cannot have received: radiotherapy

Exception: within 14 days

Received radiotherapy within 14 days