Phase I Study of the Administration of EBV CTLs Expressing CD30 Chimeric Receptors for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CAR CD 30)
Earlier, patients gave us blood to make CD30 chimeric-EBV CTLs in the lab. These cells were
grown and frozen for the patient. To get the CD30 antibody to attach to the surface of the T
cell, we inserted 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.
INCLUSION CRITERIA:
PROCUREMENT
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs),
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs), genetically modified to express an artificial T-cell receptor (CAR) targeting the CD30 molecule (CAR.CD30), in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
6 weeks
Yes
Helen E Heslop, MD
Principal Investigator
Baylor College of Medicine/Center for Cell and Gene Therapy
United States: Institutional Review Board
26617-CAR CD 30
NCT01192464
March 2011
October 2026
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |
The Methodist Hospital | Houston, Texas 77030 |