OncoMatch/Clinical Trials/NCT05432635
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
Is NCT05432635 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Anti-CD19-CAR CMV-specific T-lymphocytes and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine for b-cell non-hodgkin lymphoma.
Treatment: Anti-CD19-CAR CMV-specific T-lymphocytes · Multi-peptide CMV-Modified Vaccinia Ankara Vaccine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 overexpression
COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy
Required: CMV seropositive
Patient must be CMV seropositive
Prior therapy
Must have received: first line therapy
first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy
Cannot have received: autologous stem cell transplant
Prior autologous/allogeneic stem cell transplant
Cannot have received: allogeneic stem cell transplant
Prior autologous/allogeneic stem cell transplant
Lab requirements
Blood counts
Absolute neutrophil count >= 1000/uL (no transfusions/growth factors at screening); Hemoglobin >= 8 g/dl (no transfusions/growth factors at screening); Platelet count >= 50,000/uL (>= 30,000/uL if bone marrow plasma cells >= 50% of cellularity; no transfusions/growth factors at screening)
Kidney function
Serum creatinine <= 2.5 x ULN or estimated creatinine clearance of >= 40 mL/min per Cockcroft-Gault formula, and not on hemodialysis
Liver function
Total serum bilirubin <= 2.0 mg/dL (<= 3.0 mg/dL if Gilbert syndrome); AST < 2.5 x ULN; ALT < 2.5 x ULN
Cardiac function
Left ventricular ejection fraction >= 45% within 8 weeks before enrollment; Oxygen saturation > 92% without requiring supplemental oxygen
Total serum bilirubin <= 2.0 mg/dL; Participants with Gilbert syndrome may be included if their total bilirubin is <= 3.0; AST < 2.5 x ULN; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05432635 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous stem cell transplant, allogeneic stem cell transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Does this trial require CMV?
Yes, CMV seropositive is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify