RecruitingPhase 1NCT05432635

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

Pilot/Feasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)

Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge treatment for B-cell Non-Hodgkin Lymphoma (a type of blood cancer) that has come back or stopped responding to treatment. It uses genetically engineered T-cells (CAR T-cells) combined with a vaccine to help the immune system target and destroy cancer cells after a stem cell transplant. **You may be eligible if:** - You are 18 or older - You have intermediate or high-grade B-cell Non-Hodgkin Lymphoma - You are being considered for a stem cell transplant - You are in good enough physical condition (Karnofsky score ≥70) - Your life expectancy is at least 16 weeks at the time of enrollment **You may NOT be eligible if:** - You do not have B-cell lymphoma - You are not eligible for a stem cell transplant - Your physical condition or organ function is too poor for the treatment 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

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

Undergo autoHSCT

BIOLOGICALMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDUREMyeloablative Conditioning

Given standard conditioning regimen

Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05432635