CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics
St. Jude Children's Research Hospital
Summary
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The main purpose of this study is to determine: * Evaluate different doses of fludarabine prior CAR T cell infusion * How your body processes fludarabine and cyclophosphamide, * How long the CAR T cells last in the body, * Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and * The side effects of this therapy.
Description
CAR19PK is a Phase II study evaluating lymphodepleting chemotherapy (age-based fludarabine dosing and cyclophosphamide), followed by infusion of CD19-CAR T cells, in pediatric and young adult patients ≤ 21 years old with relapsed/refractory CD19-positive leukemia. Treatment will include a single course of lymphodepleting chemotherapy followed by CAR T cell infusion. Lymphodepletion will include fludarabine (dosing based on age) and cyclophosphamide. The CAR T cell infusion will include a single infusion of 3x10\^6 CD19-CAR T cells/kg patient weight. This protocol contains a two-part consent p…
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- No
Autologous Apheresis and Manufacturing Inclusion Criteria: * CD19+ leukemia\*\* with any of the following: * Refractory disease (primary or in relapse) * 2nd or greater relapse * Any relapse after allogeneic hematopoietic cell transplantation * 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT * must be confirmed to be CD19+ within 3 months prior to enrollment for treatment * Age: ≤ 21 years of age * Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A) * Estim…
Interventions
- DrugFludarabine
Given IV
- DrugCyclophosphamide
Given IV
- DrugMesna
Given IV
- BiologicalCD19-CAR T cell Infusion
Patients will receive the CD19-CAR T cells by vein, through either an IV or a central line.
Location
- St. Jude Children's Research HospitalMemphis, Tennessee