CAR T-Cells + CMV-MVA Triplex Vaccine for Non-Hodgkin's Lymphoma
Trial Summary
What is the purpose of this trial?
This phase I trial studies the safety and feasibility of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T cells in combination with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following lymphodepletion in treating patients with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refectory). CAR T cells are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine may help prevent the cancer from coming back.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does exclude those using systemic steroids or chronic immunosuppressants. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment CAR T-Cells + CMV-MVA Triplex Vaccine for Non-Hodgkin's Lymphoma?
Research shows that combining CMV-specific T cells with CD19 CAR T cells can improve tumor control by enhancing the persistence and effectiveness of the T cells. Additionally, CMV-specific T cell therapy has been effective in restoring immunity in patients with CMV infections, suggesting potential benefits in boosting the immune response in cancer treatment.12345
Is the CAR T-Cells + CMV-MVA Triplex Vaccine treatment generally safe for humans?
CAR T-cell therapy, including those targeting CD19, can cause side effects such as infections, cytokine release syndrome (a severe immune reaction), and other organ-related toxicities. While these treatments can be effective, they come with risks that are still being studied, especially regarding long-term safety.16789
What makes the CAR T-Cells + CMV-MVA Triplex Vaccine treatment unique for Non-Hodgkin's Lymphoma?
This treatment is unique because it combines CAR T-cells, which are engineered to target cancer cells, with a CMV-MVA Triplex Vaccine that boosts the immune system's response to cytomegalovirus (CMV), potentially enhancing the effectiveness and persistence of the CAR T-cells in fighting lymphoma.110111213
Research Team
Leslie Popplewell, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
Adults with relapsed or refractory B-cell non-Hodgkin lymphoma, who are CMV seropositive and have a life expectancy of at least 16 weeks. They must be in good physical condition (KPS >= 70), not pregnant, willing to use birth control, and without significant heart, liver or kidney issues. Excluded are those with active autoimmune disease on treatment, recent allogeneic stem cell transplant recipients, or anyone on investigational agents.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Patients undergo leukapheresis to collect T cells for modification
Lymphodepletion
Patients receive lymphodepleting chemotherapy as per standard of care
Treatment
Patients receive CMV-specific CD19-CAR T cells intravenously and CMV-MVA triplex vaccine intramuscularly
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Anti-CD19-CAR CMV-specific T-lymphocytes
- Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator