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Recruiting Phase 1 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

Trial Parameters

Condition B-Cell Non-Hodgkin Lymphoma
Sponsor City of Hope Medical Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-01
Completion 2028-03-07
Interventions
Anti-CD19-CAR CMV-specific T-lymphocytesAutologous Hematopoietic Stem Cell TransplantationMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

Brief Summary

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.

Eligibility Criteria

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 achiev

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