Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2026-02-23
15
Participants Needed
1
Research Sites
282 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 side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. 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 a chimeric antigen receptor (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 following a stem cell transplant 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) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent if appropriate
- Agreed to allow use of archival tissue from diagnostic tumor biopsies, or obtained approval for exception
- Aged 18 years or older
- Karnofsky performance status (KPS) of 70 or higher
- Life expectancy of at least 16 weeks at enrollment
- Diagnosed with intermediate or high-grade B-cell non-Hodgkin lymphoma in first relapse after complete remission or without complete remission after first therapy
- No known contraindications to myeloablative stem cell transplant, leukapheresis, steroids, tocilizumab, smallpox vaccine, or other MVA-based vaccines
- CMV seropositive
- Total serum bilirubin 2.0 mg/dL or less (up to 3.0 mg/dL for Gilbert syndrome patients)
- Aspartate aminotransferase (AST) less than 2.5 times upper limit of normal
- Alanine aminotransferase (ALT) less than 2.5 times upper limit of normal
- Serum creatinine 2.5 times upper limit of normal or less or estimated creatinine clearance of 40 mL/min or higher, not on hemodialysis
- Absolute neutrophil count of at least 1000/uL without transfusions or growth factors at screening
- Hemoglobin 8 g/dL or higher without transfusions or growth factors at screening
- Platelet count of 50,000/uL or higher (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
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control or abstain from sex during the study and for 6 months after
You will not qualify if you...
- Prior autologous or allogeneic stem cell transplant
- Use of growth factors within 14 days before enrollment
- Platelet transfusions within 7 days before enrollment
- Current systemic steroid use or chronic immunosuppressive therapy (inhaled or topical steroids at standard doses allowed; physiologic steroid replacement allowed)
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Receiving other investigational agents, biological therapy, chemotherapy, or radiation therapy
- Contraindications to myeloablative stem cell transplant per standard care
- Clinically significant arrhythmia or unstable arrhythmias within 2 weeks before screening
- History or diagnosis of optic neuritis, central nervous system inflammatory disease, seizure disorder, CNS masses, or other active CNS disease (except treated disease in remission)
- History of allergic reactions to similar compounds or cetuximab
- Known bleeding disorders such as von Willebrand's disease or hemophilia
- Stroke or intracranial hemorrhage within 6 months before screening
- History of other malignancies unless surgically resected or treated with curative intent and no active disease for 3 or more years
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- HIV positive
- Active viral hepatitis
- Pregnant or breastfeeding females
- Any other condition judged by the investigator to contraindicate participation due to safety
- Inability to comply with study procedures or feasibility/logistical issues
AI-Screening
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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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