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
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ Documented informed consent of the participant and/or legally authorized representative
- ✓ Assent, when appropriate, will be obtained per institutional guidelines
- ✓ Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- ✓ If unavailable, exceptions may be granted with study principal investigator (PI) approval
- ✓ Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed
- ✓ Age: \>= 18 years
- ✓ Karnofsky Performance Status (KPS) \>= 70
- ✓ Life expectancy \>= 16 weeks at the time of enrollment
You may not qualify if…
- ✕ Prior allogeneic stem cell transplant unless the participant has recovered from transplantation and does not have active graft versus host disease (GVHD)
- ✕ Growth factors within 14 days of enrollment
- ✕ Platelet transfusions within 7 days of enrollment
- ✕ Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\< 5 mg/day, or equivalent doses of other corticosteroids) is allowed
- ✕ Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed
- ✕ Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy
- ✕ Any standard contraindications to lymphodepleting chemotherapy and/or CAR T-cell therapy per standard of care practices at COH
- ✕ Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening
Where it's recruiting
Duarte
Source: ClinicalTrials.gov · NCT05801913 · last updated 2026-03-05