The purpose of this study is to determine if it is possible to treat your cancer with a new type of T cell-based immunotherapy (therapy that uses your immune system to treat the cancer). T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within your body that have been modified outside of the body and returned to target your cancer. 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 chimeric antigen receptor T cells (CAR T cells). Another purpose of this study is to learn about the side effects and toxicities related to this treatment.
Primary Objective: To determine the safety of the treatment of relapsed or refractory B cell lymphomas with chimeric antigen receptor T cells targeting cluster of differentiation antigen 19 (CD19) and to find the recommended phase II dose for this cellular therapy Secondary Objectives * To describe the safety profile of the infusion of CAR-T cells targeting CD19. * To describe the toxicities related to infusion of CAR-T cells targeting CD19. * To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Cyclophosphamide 60mg/Kg on day -6
Fludarabine 25mg/m\^2 IV on days -5 to -3
Chimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0 Level -1 (1 x 105 cells/kg) Level 1 \[Starting dose\] (5 x 105 cells/kg) Level 2 (1 x 106 cells/kg) Level 3 (2 x 106 cells/kg)
Washington University School of Medicine
St Louis, Missouri, United States
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Number of patients with Lymphoma response
The 2014 Lugano Response for Malignant Lymphoma will be used the following categories of response: : Complete Response (CR), Partial Response (PR), Stable Disease (SD), Relapse and Progression (PD).
Time frame: Up to 12 months after getting CAR-T infusion
Duration of response
This is measured, only in responders, from the documented beginning of response (CR or PR) to the time of relapse.
Time frame: Up to 12 months after getting CAR-T infusion
Disease-free survival
Survival is defined as the date of study entry to the date of death. Disease-free survival is measured from the time of occurrence of disease-free state to disease recurrence or death from lymphoma or acute toxicity of treatment.
Time frame: Up to 12 months after getting CAR-T infusion
Disease-specific survival
To minimize the risk of bias, the event should be recorded as death from lymphoma, or from toxicity from the drug. Death from unknown causes should be attributed to the drug.
Time frame: Up to 12 months after getting CAR-T infusion
Progression-free survival
Progression-free Survival (PFS) is defined as the time from entry onto study until lymphoma progression or death from any cause.
Time frame: Up to 12 months after getting CAR-T infusion
Time to progression
Time to progression (TTP) is defined as the time from study entry until lymphoma progression or death due to lymphoma.
Time frame: Up to 12 months after getting CAR-T infusion
Time to treatment failure
Time to treatment failure (event-free survival) is measured from the time from study entry to any treatment failure including discontinuation of treatment for any reason
Time frame: Up to 12 months after getting CAR-T infusion
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