Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neoplasm, Residual

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Neoplastic Processes

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.

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

CART 19

Noelle Frey, MD

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.

CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

Phase 2 Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) for Adult Patients With Minimal Residual Disease During Upfront Treatment for Acute Lymphoblastic Leukemia

The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment

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.

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.

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.

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)

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.

Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS).

University of Pennsylvania

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.

CART 19: 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

CART19

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Regulatory Lead

The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%

Best Overall Survival (OS)

Duration of Remission (DOR)

Relapse Free Survival (RFS)

Event Free Survival (EFS)

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.

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).

Spots Global Cancer Trial Database for CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial