Administration of T Lymphocytes for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma (CART CD30)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
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
When the patient enrolls on this study, they will be assigned a dose of CD30 chimeric receptor-activated T cells. The dose level of cells that they will receive will not be based on a medical determination of what is best for the patient, instead the dose is based on the order in which the patient e...
When the patient enrolls on this study, they will be assigned a dose of CD30 chimeric receptor-activated T cells. The dose level of cells that they will receive will not be based on a medical determination of what is best for the patient, instead the dose is based on the order in which the patient enrolled 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. The patient will be given an injection of CD30 chimeric receptor-activated T cells into the vein through an IV line at the assigned dose. The injection will take 1-10 minutes. Investigators will follow the subject in the clinic after the injection for up to 4 hours. To learn more about the way the CD30 chimeric receptor-activated T cells are working and how long they last in the body, extra blood will be drawn. If the patient has stable disease (the lymphoma did not grow) or there is a reduction in the size of the lymphoma on imaging studies after the T-cell infusion, s/he can receive up to six additional doses of the T cells at 8 to 12 weeks intervals if s/he wishes. After each T-cell infusion, s/he will be monitored as described above.
Tracking Information
- NCT #
- NCT01316146
- Collaborators
- The Methodist Hospital Research Institute
- Baylor College of Medicine
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Investigators
- Principal Investigator: Barbara Savoldo, MD, PhD University of North Carolina, Chapel Hill