EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hodgkin's Lymphoma
- Non Hodgkin's Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The EBV CTLs will be made for specific patients. First blood will be collected from the patient and then the the CD30 chimeric-EBV CTLs will be created in the lab. The cells will then be grown and frozen for the patient. To get the CD30 antibody to attach to the surface of the T cell, the lab will i...
The EBV CTLs will be made for specific patients. First blood will be collected from the patient and then the the CD30 chimeric-EBV CTLs will be created in the lab. The cells will then be grown and frozen for the patient. To get the CD30 antibody to attach to the surface of the T cell, the lab will insert the antibody gene into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. Because the patient will have received cells with a new gene in them they will be followed for a total of 15 years to see if there are any long term side effects of gene transfer. When the patient is enrolled on this study, they will be assigned to one of the following dose levels of CD30 chimeric receptor-EBV CTLs. 2×10^7 cells/m2 5x10^7 cells/m2 1×10^8 cells/m2 The dose level of cells that they will receive will not be based on a medical determination of what is best for them, instead the dose is based on the order in which the patient enrolls on the study relative to other participants. Subjects enrolled earlier in the study will receive a lower dose of cells than those enrolled later in the study. The risks of harm and discomfort from the study treatment may bear some relationship to the dose level. The potential for direct benefit, if any, may also vary with the dose level. To enroll on this study they will need to have recovered from toxic effects of previous chemotherapy for at least one week and not be receiving any other investigational agents. Patients cannot have received any tumor vaccines within the previous six weeks.
Tracking Information
- NCT #
- NCT01192464
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- The Methodist Hospital System
- Investigators
- Principal Investigator: Helen E Heslop, MD Baylor College of Medicine/Center for Cell and Gene Therapy
Get Well Soon