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Compassionate Use Re-Infusion of ATLCAR.CD30

NCT03914885 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-12-03

No results posted yet for this study

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.

Conditions

  • Hodgkin Lymphoma, Adult

Interventions

GENETIC

ATLCAR.CD30

Administered at a dose of 2 x 10\^8 cells/m2

DRUG

Bendamustine

Administered as a dose of 70mg/m2/day over 3 consecutive days; maybe dose reduced per treating physician discretion based on prior toxicities and the patient's clinical status

DRUG

Fludarabine

Administered at a dose of 30mg/m2/day over 3 consecutive days; given concomitantly with bendamustine

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Natalie Grover, MD · UNC Lineberger Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914885 on ClinicalTrials.gov