Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Pilot Study to Evaluate the Safety and Feasibility of Cellular Immunotherapy Using Genetically Modified Autologous CD20-Specific T Cells For Patients With Relapsed or Refractory Mantle Cell and Indolent B Cell Lymphomas
This phase I trial is studying the side effects of giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin in treating patients with relapsed or refractory mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Aldesleukin may stimulate the white blood cells to kill lymphoma cells. Giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin may be an effective treatment for mantle cell lymphoma and B-cell non-Hodgkin lymphoma
PRIMARY OBJECTIVES:
I. To assess the feasibility, safety and toxicity of cellular immunotherapy utilizing
ex-vivo expanded autologous T cells genetically modified to express a "second generation'
cluster of differentiation (CD)20-specific scFvFc:CD28:CD137:zeda chimeric immunoreceptor in
patients with recurrent or refractory CD20+ mantle cell or indolent lymphoma.
SECONDARY OBJECTIVES:
I. To determine the duration of in vivo persistence of adoptively transferred CD20-specific
T cells transfected with a CD20-specific scFvFc:CD28:CD137:zeda chimeric immunoreceptor.
II. To assess the trafficking of CD20-specific T cells to lymphoma masses. III. To evaluate
the development of host anti-CD20 scFvFc:CD28:CD137:zeda chimeric immunoreceptor and
anti-neomycin-resistance gene (NeoR) immune responses in study subjects.
OUTLINE:
CHEMOTHERAPY: Patients receive cyclophosphamide IV over 60 minutes.
IMMUNOTHERAPY: Beginning 2 days after completion of cyclophosphamide, patients receive
autologous CD20-specific T-cells IV over 30 minutes. Treatment repeats every 2-5 days for 3
courses.
MAINTENANCE THERAPY: Beginning 2 hours after the last T-cell infusion, patients receive
low-dose aldesleukin subcutaneously twice daily for 14 days.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Subjects who have achieved at least a partial remission lasting a minimum of 6 months may,
on a case-by-case basis, receive additional stored T cells following relapse.
After completion of study treatment, patients are followed up weekly for one month, monthly
for 1 year, and then annually for up to 2 years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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