This phase 1 trial is investigating the effectiveness and safety of a new T-cell therapy for relapsed or unresponsive lymphoma. The main outcome to be measured will be the side effects of treatment and long-term survival. This study is being conducted in Chapel Hill, North Carolina, United States.
The details
In cancer therapy, antibodies bind to cancer cells to help the body’s immune system attack them. T-cells are also used in cell therapies. T-cells are immune system cells that help fight infections. Both treatments have shown promise when given alone. In this study, T-cells and antibodies are combined to create a more effective treatment.
This study is evaluating the safety and effectiveness of a new T-cell therapy that combines T-cells and antibodies. The main outcomes to be measured will be the side effects of treatment and long-term survival.
Who are they looking for?
This trial is recruiting 36 patients with relapsed or unresponsive lymphoma who have failed 2 or more prior treatments. Patients must have previously received brentuximab vedotin treatment. Patients with Hodgkin’s lymphoma must have either failed autologous stem cell transplantation (autoSCT) or be ineligible for autoSCT.
Patients should not be taking medications such as prednisone at doses of 10 milligrams or more. Patients should not have active infections and should not have a tumor that blocks the airway.
How will it work
Patients will first receive bendamustine (Treanda) and fludarabine (Fludara) treatment to get rid of any remaining cancer cells. Then, patients will receive one or two infusions of T cells (immune cells). There are two types of T cells. Patients will receive either one or both types of cells.
The first type of cells is genetically modified to make a special antibody. This antibody sticks to lymphoma cells to help the T cells attack the cancer cells. The second type of cells is genetically modified to make a special protein called CCR4. This protein also helps the T-cells attack cancer cells.
Safety will be measured as the number of patients who experience side effects within 6 weeks of starting treatment. Effectiveness will be measured as average survival at follow-up. Patients will be followed-up for 15 years.
