| Primary Endpoint:|
To determine the progression-free survival of the patients, defined as the proportion of patients
who have not relapsed or died within 16 months following the first CT-011 treatment (18 months
following autologous PBSCT)
1. Evaluate the toxicity and safety of CT-011 in patients with DLBCL.
2. Evaluate the event free survival (events are defined as relapse, second malignancy or death) in patients treated with CT-011.
3. Evaluate the overall survival in patients treated with CT-011.
4. Evaluate reasons patients do not receive CT-011 treatment after transplant.
5. Monitoring the following biological and cellular markers in patients treated with CT-011:
a. Serum TNF-alpha and Interferon-gamma levels.
b. Peripheral blood lymphocyte and myeloid cell surface markers: CCR7, CD3, CD4, CD8, CD14, CD16, CD20, CD25, CD56, 45RO, 62L, 107a, CD127, B7-H1, B7-DC, HLA-DR, and PD-1.
c. Binding of CT-011 to CD4+, CD8+, and CD56+ lymphocytes
6. Evaluate the immunogenicity of CT-011 in patients with DLBCL.