OncoMatch/Clinical Trials/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
Is NCT05801913 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 high grade b-cell non-hodgkin's lymphoma.
Treatment: Anti-CD19-CAR CMV-specific T-lymphocytes · Multi-peptide CMV-Modified Vaccinia Ankara Vaccine — This phase I trial studies the safety and feasibility of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T cells in combination with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following lymphodepletion in treating patients with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refectory). 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 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 may help prevent the cancer from coming back.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (CD19+)
COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy
Prior therapy
Must have received: autologous hematopoietic cell transplantation — not eligible for, or who refuse, or have previously received
who are not eligible for, or who refuse, or have previously received autologous hematopoietic cell transplantation (autoHCT)
Cannot have received: allogeneic stem cell transplant
Exception: unless the participant has recovered from transplantation and does not have active graft versus host disease (GVHD)
Prior allogeneic stem cell transplant unless the participant has recovered from transplantation and does not have active graft versus host disease (GVHD)
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; O2 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 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
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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