This Phase 2 study is evaluating the safety and effectiveness of a new T-cell therapy for B-cell non-Hodgkin’s lymphoma (NHL) that has come back or stopped responding to treatment. The main outcomes to be measured will be the number of patients who experience side effects and overall response after treatment. This trial is recruiting across the United States.
For patients with aggressive NHL, chemoimmunotherapy remains the standard first-line treatment. While most patients respond to treatment, relapse is common. Many patients also develop tumors that no longer respond to treatment (refractory). Lisocabtagene maraleucel is a new type of T-cell therapy that may help induce a response in these patients.
This study is evaluating the safety and effectiveness of lisocabtagene maraleucel for patients with relapsed or refractory B-cell NHL. The main outcome to be measured will be the number of patients who experience side effects after treatment. The number of patients who respond to treatment and survival outcomes will also be measured.
Who are they looking for?
This study is recruiting 50 patients with B-cell NHL. Patients should have cancer that has come back or stopped responding to treatment. Patients should have had at least 2 lines of previous therapy. Patients must agree to use contraception. Women who are pregnant or breastfeeding cannot participate in this study. Patients should have adequate bone marrow, heart, lung, kidney, and liver function.
Patients with cancer present only in the brain or spinal cord cannot participate in this study. Patients who have had allogeneic stem cell transplant (SCT) or T-cell therapy before cannot participate. Patients with graft-versus-host disease (a complication of SCT) cannot participate. Patients with hepatitis, HIV, or uncontrolled infections cannot participate. Patients with a history of another cancer that has not been in remission for at least 2 years cannot participate. Patients with a history of heart conditions within the past 6 months cannot participate.
How will it work
All patients will be treated with chemotherapy followed by lisocabtagene maraleucel. Then, patients will be followed-up for 2 years after treatment. Safety, disease status, and quality of life will be measured during this follow-up period. Then, patients will be followed-up over a longer period, for up to 15 years after treatment.
The main outcome to be measured will be the number of patients who experience side effects after treatment. Response to treatment, overall survival, and progression-free survival (time from treatment until tumor growth or spread) will also be measured.