Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Non Hodgkin Lymphoma
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study seeks to determine the safety of the treatment of relapsed or refractory B cell lymphomas, relapsed/ refractory chronic lymphocytic leukemia and relapsed/refractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the recommended phase II dose...

This study seeks to determine the safety of the treatment of relapsed or refractory B cell lymphomas, relapsed/ refractory chronic lymphocytic leukemia and relapsed/refractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the recommended phase II dose for this cellular therapy. T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within the body that have been modified outside of the body by a lentivirus and then returned to the participant by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells, which then could be used to change the course of a disease. This type of treatment is sometimes referred to as adoptive cell transfer (ACT). In this study the specific type of cells that will be used is called human chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused to the body are modified using a lentivirus that is no longer active. The CAR-T cells will be returned to the body through an intravenous (IV) infusion. Another purpose of this study is to learn about the side effects and toxicities related to this treatment. Human CAR-T cell therapy is investigational (experimental) and works by removing T cells from the blood and modifying them to be able to target the cancer.

Tracking Information

NCT #
NCT04732845
Collaborators
Not Provided
Investigators
Principal Investigator: Benjamin Tomlinson, MD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center