Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2026-03-05
15
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and assent if appropriate
- Agreed to allow use of archival tumor tissue or obtained approval for exceptions
- Age 18 years or older
- Karnofsky Performance Status of 70 or higher
- Life expectancy of at least 16 weeks
- Diagnosed with relapsed or refractory intermediate or high-grade B cell non-Hodgkin lymphoma and not eligible for or refused autologous stem cell transplant
- No contraindications to leukapheresis, lymphodepleting chemotherapy, steroids, tocilizumab, or MVA-based vaccines
- CMV seropositive
- Total serum bilirubin 2.0 mg/dL or less (up to 3.0 mg/dL if Gilbert syndrome)
- AST less than 2.5 times the upper limit of normal
- ALT less than 2.5 times the upper limit of normal
- Serum creatinine 2.5 times the upper limit of normal or less, or creatinine clearance at least 40 mL/min without hemodialysis
- Absolute neutrophil count at least 1000/uL without transfusions or growth factors at screening
- Hemoglobin at least 8 g/dL without transfusions or growth factors at screening
- Platelet count at least 50,000/uL (or 30,000/uL if bone marrow plasma cells are 50% or more) without transfusions or growth factors at screening
- Left ventricular ejection fraction 45% or higher within 8 weeks before enrollment
- Oxygen saturation above 92% without supplemental oxygen
- Negative pregnancy test for women of childbearing potential
- Agreement to use birth control or abstain from heterosexual activity during the study and for 6 months after
You will not qualify if you...
- Prior allogeneic stem cell transplant with active graft versus host disease
- Growth factor use within 14 days of enrollment
- Platelet transfusions within 7 days of enrollment
- Use of systemic steroids or chronic immunosuppressants (inhaled or topical steroids in standard doses allowed; low-dose physiologic steroids allowed)
- Active autoimmune disease requiring systemic immune suppressive therapy
- Receiving other investigational agents, biological therapy, chemotherapy, or radiation therapy
- Contraindications to lymphodepleting chemotherapy or CAR T-cell therapy per standard practices
- Unstable or significant arrhythmias within two weeks of screening
- History or diagnosis of optic neuritis or other CNS inflammatory diseases, including seizure disorder or active CNS disease (except treated CNS disease in remission)
- Allergic reactions to compounds similar to study agents or cetuximab
- Known bleeding disorders
- History of stroke or intracranial hemorrhage within 6 months before screening
- History of other malignancies except certain treated cancers with no active disease for 3 or more years
- Uncontrolled illness
- Active infection requiring antibiotics
- Positive for HIV
- Active viral hepatitis
- Pregnant or breastfeeding females
- Any condition that would prevent safe participation or compliance with study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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