This phase 2 clinical trial will test the effectiveness of axicabtagene ciloleucel (KTE-C19) in treating relapsed or refractory (unresponsive to treatment) indolent non-Hodgkin’s lymphoma (iNHL). The primary outcome will be measured by the response rate.
The details
Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T-cell therapy that uses the patient’s own T-cells (immune cells) to fight lymphoma. The patient’s T-cells are taken and genetically engineered to express a receptor for a specific protein found on cancerous B-cells. The T-cells are then able to identify which cells are cancerous and initiate an attack against them.
The study will examine the response rate up to 6 months, time to disease progression, overall survival, and negative side effects up to 12 months.
Who are they looking for?
This trial is recruiting 50 patients with iNHL. Participants should have experienced progression within 24 months of diagnosis after being treated with immunochemotherapy, or within 6 months after completing a second-line therapy containing both an anti-CD20 antibody and alkylating agent (such as cyclophosphamide), or any point after autologous (from the patient) stem cell transplant.
Patients should not have lymphoma involvement with the heart or nervous system. Those with follicular lymphoma cannot have stage 3b or 4 disease. Ideal candidates should not have received systemic therapy for at least 2 weeks prior to entry or autologous stem cell transplant within 6 weeks prior to enrollment. Participants should have adequate organ function.
How will it work
Participants will undergo leukapheresis (a way to filter the blood) to remove white blood cells. These cells will then be genetically engineered to manufacture axicabtagene ciloleucel.
Patients will receive fludarabine (Fludara) and cyclophosphamidechemotherapy drugs intravenously (through IV) during the first 3 days. A single intravenous infusion of axicabtagene ciloleucel will then be delivered. Participants will stay in the hospital for at least 7 days during the procedure. Participants will be followed for up to three and a half years.
