KTE-X19 is an experimental therapy being developed by Kite Pharma, a Gilead Sciences company, to treat relapsed or refractory mantle cell lymphoma (MCL) and non-Hodgkin’s lymphoma. KTE-X19 also is being evaluated for the treatment of acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia.
How does KTE-X19 work?
Lymphoma is a type of cancer that affects lymphocytes (a type of white blood cell). The cancerous cells travel through the bloodstream, dividing and growing more than they should. Lymphomas often spread beyond the blood, growing in lymph nodes, the spleen, and other areas in the body.
KTE-X19 is a type of CAR T-cell therapy that modifies patients’ own cells to treat their cancer. The patient’s blood is collected through a process similar to giving blood or getting blood drawn at a hospital or clinic. From this blood, T-cells, a type of immune cell, are harvested. The T-cells are activated and genetically modified to produce a chimeric antigen receptor (CAR). This chimeric molecule has an antigen-binding site similar to an antibody on one end, and a component that signals the T-cells to remain active on the other.
The modified T-cells are then expanded and infused back into the patient. The CAR T-cells specifically recognize a surface marker called CD19 that is found on some types of lymphoma cells. The treatment works by bringing those activated T-cells close to cancerous cells, targeting them for destruction.
KTE-X19 in clinical trials
An open-label Phase 2 clinical trial (NCT02601313) recruited 74 patients with relapsed or refractory MCL. The goal of the trial is to evaluate the safety and effectiveness of a single infusion of KTE-X19 following a conditioning treatment of fludarabine and cyclophosphamide, two other cancer-fighting medications. The primary goal is the objective response rate to treatment. The trial is ongoing, but no longer recruiting participants.
Preliminary results have shown an overall response rate of 93%, of which 67% of patients achieved a complete response (disappearance of all cancer). In the safety analysis, 15% of patients experienced severe cytokine release syndrome and 31% experienced neurological events.
A Phase 1/2 clinical trial (NCT02625480) is currently recruiting an estimated 116 patients up to age 21 with relapsed or refractory B-precursor ALL ,or relapsed or refractory B-cell non-Hodgkin’s lymphoma in the U.S., Canada, France, and the Netherlands to assess the safety and effectiveness of KTE-X19. The participants will receive a conditioning treatment of fludarabine and cyclophosphamide followed by a single infusion of KTE-X19. The primary outcome measure of the first phase will be the percentage of patients who experience adverse side effects up to 28 days following the infusion. In the second phase, the primary outcome measure will be the overall complete remission rate.
A similar Phase 1/2 clinical trial (NCT03624036) will evaluate the safety and effectiveness of KTE-X19 in adults with ALL or non-Hodgkin’s lymphoma. The trial is currently recruiting an estimated 108 participants in the U.S., Germany, Italy, and Spain. Participants will receive a conditioning treatment of fludarabine and cyclophosphamide followed by a single infusion of KTE-X19. In the first phase of the trial, the primary outcome measure will be the dose-limiting toxicity of the treatment, while in the second phase, it will be the objective response rate.
Kite Pharma submitted a marketing authorization application to the European Medicines Agency (EMA) for KTE-X19, which is currently under review. Similarly, Kite has submitted a biologics license application to the U.S. Food and Drug Administration (FDA). The therapy already has been granted breakthrough therapy designation by the FDA and priority medicines (PRIME) status by the EMA.
Last updated: Feb. 4, 2020
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