This phase 1 study is evaluating the safety and effectiveness of a new T-cell therapy combined with nivolumab (Opdivo) for patients with lymphoma that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have side effects. This study is recruiting in Washington, D.C. and Salt Lake City, Utah, US.
The details
Tumor-associated antigen-specific (TAA) T-cell therapy is a new cell therapy under investigation. T-cells (immune cells) are collected from the patient. The cells are modified to recognize tumor proteins. Then, these T-cells are introduced to the patient. Nivolumab is an immunotherapy. It works by making cancer cells more prone to be destroyed by the immune system.
This study is evaluating the safety and effectiveness of TAA-T cell therapy plus nivolumab for patients with lymphoma that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have side effects.
Who are they looking for?
This study is recruiting 18 patients with lymphoma. Patients will be divided into two groups. Group A will consist of patients with lymphoma that has come back (relapsed) or stopped responding to treatment. Group B will consist of patients with diffuse large B-cell lymphoma who have a high risk of relapse after a previous stem cell transplant.
Patients must agree to use contraception during the study. Patients who are pregnant or breastfeeding cannot participate in this study. Patients who have had an allogeneic bone marrow transplant before cannot participate in this study. Patients with autoimmune conditions, uncontrolled infections, or active HIV cannot participate. Patients treated with T-cell therapy or investigational anti-cancer therapy within 28 days of study entry cannot participate.
How will it work
All patients will receive nivolumab infusion every 2 weeks for 4 doses. These will be followed by 2 doses of TAA therapy 2 weeks apart. Patients will be monitored for side effects. Then, 2 more nivolumab doses will be given. After day 136 patients may receive a third dose of TAA.
The main outcome to be measured will be the number of patients who have side effects 45 days after starting treatment. Effectiveness will be measured as the number of patients who respond to treatment.
