This phase 1 clinical trial will test the safety of JCAR017 CAR T-cells in treating patients with relapsed or refractory (unresponsive to treatment) B-cell non-Hodgkin’s lymphoma. The primary outcome with be measured by adverse (negative) side effects, maximum dosage, response rate, and concentration of JCAR017.
The details
JCAR017 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 from the body 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 measure negative side effects up to 2 years, dose-limiting toxicity (side effects that prevent dose increase) for 28 days, response rate for 2 years, and concentrations of JCAR017 in blood and bone marrow for 1 year.
Who are they looking for?
This trial is recruiting 274 patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma. Patients must have adequate bone marrow and organ function.
Patients with history of another primary cancer must be disease free for at least 2 years. Patients with central nervous system (CNS) involvement with lymphoma are eligible as long as it is not a primary (CNS-only) involvement. Participants cannot have a history of cardiovascular disease.
Participants must not have undergone chemotherapy within 1 week, radiation within 6 weeks, or stem cell transplantation within 90 days of entering the trial.
How will it work
Patients will be divided into two groups. Initially, both groups will undergo a laboratory procedure to isolate white blood cells for the development of JCAR017. During the development, patients may receive a low dose of chemotherapy to control the disease. The first group will then receive a single intravenous dose (delivered through IV into a vein) of JCAR017. The second group will receive two intravenous doses of JCAR017.
Patients who respond to the treatment can receive additional cycles. Negative side effects and response rates will be measured for up to 2 years.
