This phase 1 clinical trial will test the safety of a JCAR014 engineered T cells and durvalumab(MEDI4736) combination in treating recurrent or refractory (unresponsive to treatment) non-Hodgkin’s lymphoma. The primary outcome will be measured by evaluating the movement of the engineered T cells throughout the body and side effects. This trial is being conducted at University of Washington Cancer Consortium.
The details
CAR-T cells (JCAR014) are T-cells (immune cells) that have been removed from a patient and genetically modified to attack cancer cells. These cells are then reintroduced into the patient. Durvalumab is an immunotherapy. It uses the body’s own immune system to identify and kill cancer cells. The drug works by inhibiting proteins on immune cells that normally reduce immune response. This may increase the effectiveness of JCAR014. The combination of therapies has the potential to provide a robust immune response against cancerous B-cells.
The study will examine the concentration of the CAR-T cells in blood, the maximum dose, overall survival, response to treatment, and time to disease progression.
Who are they looking for?
This trial is recruiting 42 patients with relapsed or refractory diffuse large B-cell non-Hodgkin’s lymphoma. Patients with refractory disease should have received at least one immuno-chemotherapy or at least two types of other therapies. Participants with relapsed disease should have either received one chemo-immunotherapy and are not eligible for hematopoietic (blood) stem cell transplant or at least two types of other therapies.
Patients cannot have central nervous system (CNS) involvement with the disease, autoimmune diseases, and organ transplant, or symptomatic heart conditions within 6 months of enrollment. Participants should not have received a live, attenuated vaccine 28 days prior to the trial. Patients must have adequate heart, lung, liver, and kidney function. Patients should not have any uncontrolled infection.
How will it work
Patients will be divided into two treatment groups. Group 1 will receive JCAR014 intravenously (through IV) for 20-30 minutes on day 0 and durvalumabintravenously for 1 hour on day 28 and every 4 weeks after for up to 10 doses as long as there is no evidence of disease progression or unacceptable side effects.
Group 2 will receive durvalumab intravenously for 1 hour on days -28 and -1, and JCAR014 intravenously for 20-30 minutes on day 0. Patients may receive durvalumab every 4 weeks for up to 11 doses.
