Actively Recruiting
Pilot Study of CMV-Specific CD19-CAR T Cells and CMV-MVA Triplex Vaccine After Autologous Stem Cell Transplant for Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma
Led by City of Hope Medical Center · Updated on 2026-02-23
15
Participants Needed
1
Research Sites
42 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and side effects of a new treatment combining cytomegalovirus CMV specific CD19-chimeric antigen receptor CAR T-cells with a CMV-modified vaccinia Ankara MVA triplex vaccine after stem cell transplant in patients with intermediate or high-grade B-cell non-Hodgkin lymphoma. This phase I trial aims to assess how well these genetically modified T-cells and the vaccine work together to prevent cancer from returning. The study also examines the production feasibility, immune response, and long-term outcomes including survival and disease progression. Participants receive a standard conditioning regimen of chemotherapy drugs starting about nine days before the transplant, followed by an autologous hematopoietic stem cell transplant autoHSCT on day -2. On day 0, patients are given an infusion of the CMV-specific CD19-CAR T-cells intravenously. The CMV-MVA triplex vaccine is then administered intramuscularly on days 28 and 56, provided there is no disease progression or unacceptable side effects. The trial includes a safety lead-in and expansion phase to evaluate the combined treatment and vaccine effects. During the study, participants are closely monitored with follow-up visits at 18-24 hours, weekly for three weeks, at one month, day 84, monthly from months 4 to 11, and at one year post-treatment. Those with disease progression or receiving prohibited therapies have additional follow-ups up to 15 years. The research team measures adverse events, immune cell persistence, CMV reactivation, progression-free survival, and overall survival to understand the treatments safety and potential benefits over time.
CONDITIONS
Brief Title
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma
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