Phase II Study of CD19-Targeted CAR T Cell Therapy for Children Aged 3 to 18 With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three autotransfusion agents targeting CD19 chimeric antigen receptor T lymphocytes BIC-19GG, BIC-2019, BIC-2219 for treating children aged 3 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that express CD19. This trial aims to understand how these treatments affect overall survival and event-free survival in this patient group. The study involves intravenous injections of CAR T cells designed to target CD19 on cancer cells. Participants receive one of the three investigational CAR T cell therapies. The treatment focuses on children with specific markers and disease characteristics who have not responded to previous standard chemotherapy or relapsed after bone marrow transplantation. During the study, children will be closely monitored for overall survival and event-free survival over 24 months after infusion. Researchers will also assess remission rates one month after treatment and track any adverse events for up to 12 months. Participants will undergo clinical evaluations, including tests of liver, kidney, heart, and lung function, as well as blood tests and antigen tests. The total duration of involvement covers at least two years post-treatment for outcome assessment.

CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+