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 (May 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
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
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