Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CART CD30)
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. To enroll on this study the patient will need to have recovered from toxic
effects of previous chemotherapy for at least one week and not be receiving any other
investigational agents. The patient cannot have received any tumor vaccines within the
previous six weeks.
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. We will
follow you in the clinic after the injection for up to 4 hours.
Medical tests before study treatment—
Before being treated, the patient will receive a series of standard medical tests:
- Physical exam
- Blood tests to measure blood cells, kidney and liver function
- Pregnancy test for women of child bearing potential
- Measurements of the tumor by scans and/or bone marrow studies
Medical tests during and after study treatment—
The patient will receive standard medical tests when they are getting the infusions and
after:
- Physical exams
- Blood tests to measure blood cells, kidney and liver function
- Measurements of the tumor by scans (CT/MRI/or PET) and/or bone marrow studies at time
of infusion and at 6 weeks after the infusion
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with adverse events as a measure of safety and tolerability of escalating doses of autologous activated T lymphocytes
To evaluate the safety of escalating doses of autologous activated T lymphocytes (ATL), genetically modified to express an artificial chimeric antigen receptor (CAR) that targets the CD30 molecule (CAR.CD30) and also contains the CD28 endodomain, 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
United States: Food and Drug Administration
H-27721-CART CD30
NCT01316146
December 2011
December 2029
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |
The Methodist Hospital | Houston, Texas 77030 |