Experimental CAR T-Cell combo aims to stop lymphoma relapse after transplant
NCT ID NCT05432635
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether giving special immune cells (CMV-specific CD19-CAR T cells) along with a vaccine (CMV-MVA triplex) after a stem cell transplant can safely help prevent B-cell non-Hodgkin lymphoma from returning. About 15 people with intermediate or high-grade lymphoma will take part. The main goal is to check for side effects and see if the treatment is feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CMV-specific CD19-CAR T cells and CMV-MVA triplex vaccine
- What this could lead to
- If this works, it could point toward a new way to prevent non-Hodgkin lymphoma from coming back after a stem cell transplant.
- What could go wrong
- This is a very early, small phase 1 trial with only 15 people, so it is mainly checking safety. It may not work as hoped, and there could be side effects from the CAR T cells or vaccine.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy * 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 myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (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 limits 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 this requirement at initial screening) * Hemoglobin (Hb) \>= 8 g/dl (Transfusions and growth factors must not be used to meet this requirement at initial screening) * Platelet count \>= 50,000/uL (\>= 30,000/uL if bone marrow plasma cells are =\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening) * Left ventricular ejection fraction \>= 45 percent 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 Criteria: * Prior autologous/allogeneic stem cell transplant * 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 myeloablative HSCT 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 cells \[WBC\] / mm\^3 and no blasts in cerebrospinal 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 * Procedures (including compliance issues related to feasibility/logistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study * 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell non Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas