RecruitingPhase 1NCT05801913

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

A Pilot / Feasibility Study of Autologous CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine in Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a novel combination treatment for relapsed or refractory B-cell lymphoma: genetically modified CAR T-cells that are also programmed to specifically expand in the presence of a CMV (cytomegalovirus) vaccine. The vaccine is used to help the CAR T-cells multiply and stay active longer in your body. **You may be eligible if:** - You are 18 or older - You have relapsed or refractory intermediate or high-grade B-cell lymphoma (such as DLBCL, mantle cell, or transformed NHL) - You are not eligible for, previously had, or refused standard stem cell transplantation - Your tumor has been confirmed to be CD19-positive - You have previously been infected with CMV (a common virus) — confirmed by a blood test - You are in adequate general health (Karnofsky score at least 70) **You may NOT be eligible if:** - You have cancer in your brain or spinal cord - You have certain allergies to treatment components or smallpox/MVA vaccines - You have never had CMV infection - Your liver function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAnti-CD19-CAR CMV-specific T-lymphocytes

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT

PROCEDURELeukapheresis

Undergo leukapheresis per SOC

PROCEDURELymphodepletion Therapy

Undergo lymphodepletion chemotherapy per SOC

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDUREPositron Emission Tomography

Undergo PET

PROCEDUREX-Ray Imaging

Undergo x-ray


Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

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NCT05801913


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