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Compassionate Use Re-Infusion of ATLCAR.CD30

2019-04-17 12:55:22 | BioPortfolio

Summary

This protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This protocol combines both T cells and antibodies to create a more effective treatment. The investigational treatment is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.

Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD30. For this protocol, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.

The primary purpose of this protocol is to treat a single patient with a second dose of ATLCAR.CD30 T cells.

Description

Lymphodepleting Chemotherapy:

The patient will receive a lymphodepleting regimen of bendamustine 70mg/m2/day over 3 consecutive days and fludarabine 30mg/m2/day over 2 consecutive days. Bendamustine and fludarabine will be administered concomitantly. Dose reduction of bendamustine may occur per treating physician discretion based on prior toxicities and the clinical status of the patient.

Administration of ATLCAR.CD30 T cells:

Post lymphodepletion, if the patient meets eligibility criteria for cellular therapy, then will receive ATLCAR.CD30 T cells within 2-14 days after completing the pre-conditioning chemotherapy regimen. We will administer ATLCAR.CD30 T cells post lymphodepletion at a dose of 2 x 10^8 cells/m2.

Duration of Therapy:

Therapy under this compassionate use protocol involves 1 infusion of ATLCAR.CD30 cells.

Duration of Follow-up:

The patient will be followed for up to 15 years for replication-competent retrovirus evaluation or until death, whichever occurs first.

Study Design

Conditions

Hodgkin Lymphoma, Adult

Intervention

ATLCAR.CD30, Bendamustine, Fludarabine

Location

Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill
North Carolina
United States
27599

Status

No longer available

Source

UNC Lineberger Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-04-17T12:55:22-0400

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