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RECRUITING
NCT05432635
PHASE1

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-08-01

Completion Date

2028-12-30

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

Anti-CD19-CAR CMV-specific T-lymphocytes

Given IV

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autoHSCT

BIOLOGICAL

Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDURE

Myeloablative Conditioning

Given standard conditioning regimen

Locations (1)

City of Hope Medical Center

Duarte, California, United States