Study

CAR T-Cell Treatment for Children with Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia

In this study we want to learn more about a new treatment called CD19x22 CAR T cells. We want to see how well it works as a treatment for B-cell Acute Lymphoblastic Leukemia (B-ALL) when the cancer has come back after treatment or hasn’t responded to previous treatments.

Why this Research Matters

In this study, we are using a new technique to treat cancer. We will take some of your body's own immune cells (called T cells) and change them (engineer) to help your T cells to spot and fight your leukemia cells. If you/your child joins this study, you will be asked to come to up to 17 visits across 13 months at Children's Hospital Colorado. You could be asked to come to more visits or stay in the study longer depending on how your cancer responds to the treatment. At these visits we will ask about your medical history and perform physical exams. We will also take blood samples from your arm with a needle or through a central line. We will ask you to give urine samples. We will do disease evaluations to check your leukemia before and after treatment. We will take pictures and do tests to learn about the function of your heart before treatment. The study treatment will be given one time through a central line. You will need to stay in the hospital or close to the hospital for at least one-two months after treatment and maybe longer if clinically needed. We will also take a small blood sample from your arm with a needle, and we will ask you to give urine samples. We will perform body scans (CT scans and/or MRIs). We will take pictures and do tests to learn about the function of your heart. The study treatment will be given one time through an IV in your arm. You will need to stay in the hospital or close to the hospital for observation for 14 days after you receive the treatment.

Who can Participate

All Ages

You or your child may be able to join this study if you are between 3 months and 30 years old. If you are female, you must not be pregnant or breastfeeding. You must have B-cell Acute Lymphoblastic Leukemia (B-ALL) and have already received the standard treatment for your disease. However, to join, the leukemia must have either returned (relapsed) or not responded to treatment (refractory). Other criteria to join will be assessed by our study doctor.