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NCT05801913 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05801913 is a Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 47-participant average among 15 other Refractory B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05801913, a Phase 1 study of Refractory B-Cell Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Leukapheresis
- BIOLOGICAL Anti-CD19-CAR CMV-specific T-lymphocytes
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05801913
The ClinicalTrials.gov registry entry for NCT05801913 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 15 other Refractory B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (68% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Refractory B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05801913 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05801913 about?
NCT05801913 is a clinical study titled "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". 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-Ho...
What is the current status of trial NCT05801913?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2023-09-29. Estimated completion is 2028-12-30.
What conditions does trial NCT05801913 study?
This clinical trial studies the following conditions: Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, High Grade B-Cell Non-Hodgkin's Lymphoma, Intermediate Grade B-Cell Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT05801913?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Leukapheresis (PROCEDURE), Anti-CD19-CAR CMV-specific T-lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT05801913?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05801913 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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