CMV-Specific CD19-CAR T-cells and Vaccine for B-Cell Non-Hodgkin Lymphoma
This study is testing a new treatment for intermediate or high-grade B-cell non-Hodgkin lymphoma that has returned or isn't responding to other treatments. It combines two interventions: genetically modified T-cells (CMV-specific CD19-CAR T-cells) and a vaccine (CMV-MVA Triplex). CAR T-cells are your own immune cells that are specially trained in the lab to find and fight cancer. The study aims to see how safe these treatments are and if they cause side effects. Researchers will also look at how well the CAR T-cells work and if they help shrink the lymphoma. You might be able to join if you are 18 or older and have this type of lymphoma. The study plans to enroll 15 participants.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. It is a Phase 1 trial, focused on safety and feasibility.
- What's involved
- You would undergo procedures like blood draws, bone marrow biopsies, CT scans, and leukapheresis (a procedure to collect your T-cells).
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for side effects for up to 15 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05801913
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~15 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Anti-CD19-CAR CMV-specific T-lymphocytesBiospecimen CollectionBone Marrow BiopsyComputed TomographyLeukapheresisLymphodepletion Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicity
Measured over Up to 28 days
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Leslie L Popplewell · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Patients requiring treatment for relapsed or refractory intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], or transformed NHL) who are not eligible for, or who refuse, or have previously received autologous hematopoietic cell transplantation (autoHCT)
Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy
No known contraindications to leukapheresis, lymphodepleting chemotherapy, steroids or tocilizumab, smallpox vaccine and any other MVA-based vaccines
Patient must be CMV seropositive
Total serum bilirubin =\< 2.0 mg/dL
Participants with Gilbert syndrome may be included if their total bilirubin is =\< 3.0
Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) \< 2.5 x ULN
Serum creatinine =\< 2.5 x ULN or estimated creatinine clearance of \>= 40 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis
Absolute neutrophil count \>= 1000/uL (Transfusions and growth factors must not be used to meet these requirements at initial screening)
Hemoglobin (Hb) \>= 8 g/dl (Transfusions and growth factors must not be used to meet these requirements at initial screening)
Platelet count \>= 50,000/uL (\>= 30,000/uL if bone marrow plasma cells are \>= 50% of cellularity) (Transfusions and growth factors must not be used to meet these requirements at initial screening)
Left ventricular ejection fraction \>= 45% within 8 weeks before enrollment
Oxygen (O2) saturation \> 92% without requiring supplemental oxygen
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
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
Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease
Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\< 5 white blood cell \[WBC\]/mm\^3 and no blasts in cerebral spinal fluid \[CSF\]) will be eligible
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab
Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
History of stroke or intracranial hemorrhage within 6 months prior to screening
History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years
Clinically significant uncontrolled illness
Active infection requiring antibiotics
Immunodeficiency virus (human immunodeficiency virus \[HIV\]) positive
Active viral hepatitis
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Incidence of dose-limiting toxicityUp to 28 days
Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, and the revised American Society for Transplantation and Cellular Therapy (ASTCT) cytokine release syndrome (CRS) grading systems. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
- Incidence of adverse eventsUp to 15 years
Will be assessed and graded according to the NCI CTCAE v5.0, and the ASTCT consensus grading for CRS and neurotoxicity associated with immune effector cells.