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CAR19PK: CAR T-Cell Therapy for Leukemia

About this study

With regular treatment, most children, teens, and young adults with acute lymphoblastic leukemia (ALL) recover from their disease. But some have cancer that returns (relapses) or does not improve with treatment (refractory). For these patients, standard treatments are often less effective.

The common treatments for relapsed or refractory ALL include strong chemotherapy, radiation therapy, cell therapy, immunotherapy, or bone marrow (stem cell) transplants. These treatments can be intense and may not always lead to a cure. So, new and better treatments are needed.

CAR (chimeric antigen receptor) T-cell therapy uses 2 parts of the body’s immune system—antibodies and T cells—to help fight cancer. Before treatment, T cells are collected from the patient. In a lab, the T cells are then changed into CAR T cells. This helps the T cells find and attack cancer cells better.

CAR T-cell therapy that targets CD19 (a marker on the surface of B-cell ALL cells) has been very successful in treating patients. But not all patients respond to CD19-CAR T cell therapy. In some patients, leukemia can again relapse after treatment.

This clinical trial tests a treatment that uses chemotherapy along with CD19 CAR T-cell therapy to treat ALL. We want to test how different doses of chemotherapy affect the success of CD19 CAR T-cell therapy. This may help the treatment work better and reduce side effects.

In this study, patients will first get 2 chemotherapy drugs, fludarabine and cyclophosphamide, followed by an infusion of CAR T cells. We will use different amounts of fludarabine based on the patient's age. We will also study how their body handles chemotherapy. The CAR T cells will look for CD19 on the patient’s leukemia cells.

After treatment, patients will be followed for a total of 15 years to monitor their health and safety.

This study could help doctors understand how to make this therapy safer and more effective, giving patients with hard-to-treat leukemia a better chance at recovery and long-term survival.

Eligibility overview

  • CD19-positive relapsed or refractory acute lymphoblastic leukemia
  • Up to 21 years old

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

CAR19PK: CAR T-cell Therapy for Pediatric, Adolescent and Young Adult Patients with CD19-positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics

Study goal:

To study CAR T-cell therapy and chemotherapy agents for treating relapsed or hard-to-treat acute lymphoblastic leukemia.

Diagnosis:

Acute lymphoblastic leukemia

Age:

Up to age 21

Clinical trials categories:

Childhood Cancer Leukemia Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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