Safety and Feasibility of CMV-Specific CD19-CAR T Cells Combined with CMV-MVA Triplex Vaccine for Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are studying a new treatment approach for patients with intermediate or high-grade B-cell non-Hodgkin lymphoma NHL that has returned after improvement or does not respond to treatment. This phase I trial evaluates the safety and feasibility of using genetically modified T cells called CMV-specific CD19-CAR T cells combined with a CMV-modified vaccinia Ankara MVA triplex vaccine. The treatment aims to engage the immune system to attack cancer cells and prevent the cancer from coming back. Patients first undergo a procedure called leukapheresis about 30 days before treatment to collect T cells, followed by lymphodepleting chemotherapy from days -10 to -3 according to standard care. On day 0, patients receive an infusion of the modified T cells intravenously. They then receive the CMV-MVA triplex vaccine by intramuscular injection on days 28 and 56, provided there are no serious side effects. The study includes a dose-escalation phase followed by a dose-expansion phase to evaluate treatment effects. Throughout the study, participants will have various assessments including X-rays during screening and treatment, as well as PET, CT, and MRI scans, blood tests, and bone marrow biopsies. Researchers will monitor safety and side effects up to 15 years, measure T cell levels and disease responses at 28 and 84 days, and track survival and cancer progression over time. The total involvement includes initial treatment and long-term follow-up to assess the treatments effects and safety.

Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma