This phase 1 clinical trial will test the maximum dose of chimeric antigen receptor (CAR) T-cells in treating advanced lymphoid leukemia and lymphoma. The primary outcome will be measured by the maximum tolerated dose. This trial is being conducted at the University of Texas MD Anderson Cancer Center in Houston, Texas.
The details
CAR T-cell therapy uses the patient’s own T-cells to fight cancer cells. The patient’s T-cells are collected and genetically engineered to express a receptor for a specific protein found on cancerous lymphoid cells. After the T-cells are injected back into the body, they are able to identify which cells are cancerous and initiate an attack against them.
The study will examine the maximum tolerated dose of T-cells that can be transplanted. The main outcome to be measured are the number of side effects experienced.
Who are they looking for?
This trial is recruiting 30 patients with advanced CD19 positive B-cell leukemia or lymphoma. Participants should not have received an allogeneic (donor) stem cell transplant within 3 months of enrollment. Patients should not be HIV positive.
How will it work
Patients will initially undergo a procedure to separate T-cells from the blood. Prior to T-cell infusion, doctors will choose and administer a chemotherapy to decrease the number of lymphocytes in the body. T-cell infusion will occur by vein either in 1 day or spread over 2 days.
Patients will be followed at 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the infusion.
