This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10\^7 CART19 cells, Day 2, 30% fraction: 3x10\^7-1.5x10\^8 CART19 cells, Day 3, 60% fraction: 6x10\^7-3x10\^8 CART19 cells
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%
The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment
Time frame: Day 28
Best Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of the first CART19 infusion to the date of death due to any reason.
Time frame: one year
Duration of Remission (DOR)
Duration of remission (DOR) is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL.
Time frame: one year
Relapse Free Survival (RFS)
Relapse free survival (RFS) is defined as the duration between the date when the response criteria of CR or CRi is first met to the date of relapse or death due to any cause.
Time frame: one year
Event Free Survival (EFS)
Event free survival (EFS) is defined as the time from start of the first CART19 infusion to the earliest of the following: Death from any cause Relapse Treatment failure: Defined as no response in the study and discontinuation from the study due to any of the following reasons: * Adverse event(s) * Abnormal laboratory value(s) * Abnormal test procedure results * New cancer therapy (excluding HSCT when performed in CR or CRi)
Time frame: one year
Percentage of Manufacturing Products That do Not Meet Release Criteria for Vector Transduction Efficiency, T Cell Product Purity, Viability, Sterility or Due to Tumor Contamination.
Percentage of manufacturing products that do not meet release criteria for vector transduction efficiency, T cell product purity, viability, sterility or due to tumor contamination.
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Time frame: prior to day 1
Safety and Tolerability of CART19: Frequency and Severity of Adverse Events, Including, But Not Limited to, Cytokine Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS).
Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS).
Time frame: one year