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Genetically Engineered Lymphocyte Therapy in Treating Patients With B-Cell Leukemia or Lymphoma That is Resistant or Refractory to Chemotherapy

2014-08-27 03:17:24 | BioPortfolio

Summary

RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is resistant or refractory to chemotherapy.

Description

PRIMARY OBJECTIVES:

I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).

II. Determine duration of in vivo survival of CART-19 cells. RT-PCR analysis of whole blood will be used to detect and quantify survival of CART-19 TCR zeta:4-1BB and TCR zeta cells over time.

SECONDARY OBJECTIVES:

I. For patients with detectable disease, measure anti-tumor response due to CART-19 cell infusions.

II. To determine if the 4-1BB transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-19 TCR zeta:4-1BB and TCR zeta cells over time.

III. Estimate relative trafficking of CART-19 cells to tumor in bone marrow and lymph nodes.

IV. For patients with stored or accessible tumor cells (such as patients with active CLL, ALL, etc) determine tumor cell killing by CART-19 cells in vitro.

V. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CART-19 (loss of engraftment).

VI. Determine the relative subsets of CART-19 T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 of 2 groups according to order of enrollment.

Group 1 (Patients 1-5): Patients receive anti-CD19-CAR retroviral vector-transduced autologous T cells with 41BB-gamma vector on days 0,1, 2, and 11 in the absence of disease progression or unacceptable toxicity.

Group 2 (Patients 6-10): Patients receive anti-CD19-CAR retroviral vector-transduced autologous T cells with either 41BB-gamma vector or TCR zeta vector on days 0,1, 2, and 11 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hematopoietic/Lymphoid Cancer

Intervention

laboratory biomarker analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction, anti-CD19-CAR retroviral vector-transduced autologous T cells, genetically engineered lymphocyte therapy

Location

Abramson Cancer Center of The University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104

Status

Recruiting

Source

Abramson Cancer Center of the University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:24-0400

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