Phase I Study of Two Types of CAR T Cell Therapy for Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the feasibility and safety of two different anti-CD19 chimeric antigen receptor T cell CART therapies for children and young adults with relapsed or refractory acute lymphoblastic leukemia ALL. This study focuses on patients with CD19 B-cell ALL or T-cell ALL who have limited treatment options and aims to address the high relapse rates seen after current CART therapies. The trial is a phase I study designed to explore new treatment approaches for these hard-to-treat leukemias. The trial involves two treatment groups based on disease biomarkers. One group receives autologous dual CD19CD22 CART cells, administered as two intravenous doses with specific timing and dosing guidelines. The other group receives allogeneic CART-NKG2D cells given in up to three intravenous doses spaced 48 hours apart, depending on patient response. Treatments are tailored based on the patients leukemia type and biomarker expression, with careful monitoring for cytokine-release syndrome. Participants will undergo regular assessments including laboratory tests to monitor immune cell levels, antigen expression, and cytokine profiles over an average of five years. Safety is closely tracked through adverse event reporting, with a focus on the severity and frequency of side effects related to the CART therapies. Additional tests include DNA methylation profiling and antibody presence to understand the treatments effects. The study requires participants to have adequate organ function and provides long-term follow-up to evaluate treatment persistence and overall response.

Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults