Study of Co-Administered Humanized Anti-CD22 CART22-65s and Anti-CD19 huCART19 CAR T Cell Therapy in Children and Young Adults with Relapsed or Resistant B-Cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of giving two CAR T cell therapies, huCART19 and CART22-65s, to children and young adults with advanced B cell Acute Lymphoblastic Leukemia B-ALL. This condition often returns after initial treatment with CAR T cells, and this study aims to improve outcomes by addressing common reasons for relapse, such as loss of target antigens and immune rejection of earlier treatments. The trial includes patients who have relapsed or are resistant to prior therapies and is led by Stephan Grupp MD PhD. Participants receive two specially designed treatments CART22-65s, which targets the CD22 antigen to overcome CD19 antigen escape, and huCART19, a humanized version targeting CD19 to reduce immune rejection. The study has two phases Phase 1 focuses on safely finding a dose level without severe side effects, and Phase 2 expands to evaluate the chosen safe dose in two groups patients new to CAR T therapy and those previously treated with CAR T cells. During the study, researchers will monitor safety and effectiveness over one year, including tumor response, survival, and persistence of the CAR T cells. Additional assessments include manufacturing feasibility and bioreactivity over five years. Participants will undergo various tests such as flow cytometry to confirm tumor markers, and they must have adequate organ function and performance status. Safety monitoring includes checking for infections and immune-related effects. The total participation time depends on the study phase and follow-up requirements.

Co-administration of CART22-65s and huCART19 for B-ALL