Phase 1 Study of CD19-CD22 Bispecific CAR T Cell Therapy for Children and Young Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia Including Chemotherapy and CAR T Cell Infusion

What this Trial Is About

Researchers are evaluating a new treatment called CD19-CD22-CAR T cells in patients 21 years old or younger with recurrent or refractory acute lymphoblastic leukemia that tests positive for CD19 andor CD22. This phase I study aims to determine the safety of these engineered immune cells and find the best dose for future studies, while also assessing their ability to fight leukemia. Treatment begins with a single course of chemotherapy using fludarabine and cyclophosphamide to prepare the body, followed by an infusion of the CD19-CD22-CAR T cells. The dose of CAR T cells will be adjusted according to weight and a dose escalation plan. The study includes a collection and manufacturing phase where patients white blood cells are collected or previously stored cells are used to create the CAR T cells designed to target leukemia. Participants will be closely monitored for safety and side effects up to four weeks after the CAR T cell infusion. Researchers will measure the recommended phase 2 dose and track any adverse events. The study involves blood tests, physical exams, and assessments of heart, kidney, and lung function, along with pregnancy tests for females of childbearing age. The total participation time varies but focuses on the period around the CAR T cell infusion and early recovery.

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia