Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent
non-Hodgkin's lymphoma (NHL). Eligible patients will have relapsed or refractory disease
after receiving at least one and no more than four prior regimens. Patients will receive
Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an
attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the
study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL.
Secondary endpoints are to evaluate the safety of the therapy in this patient population, and
to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes
in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative
immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph
nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone
marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be
evaluated in patients amenable to biopsy of enlarged lymph nodes.