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NCT05665725 · ClinicalTrials.gov registry record · Phase 1
Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma
A Phase 1 study, sponsored by Timothy Voorhees.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT05665725 is a Phase 1 study that has completed, run by Timothy Voorhees. The registered enrollment target is 11 participants.
The verdict
NCT05665725, a Phase 1 study, has completed, sponsored by Timothy Voorhees.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase I trial tests the safety and side effects of siltuximab in preventing CAR T cell therapy related cytokine release syndrome in patients with CD19 positive non-Hodgkin lymphoma. Several of the major complications of CD19 directed chimeric antigen receptor T-cell therapy (CD19.CAR-T) include cytokine release syndrome (CRS, a complication of a highly active immune system seen with some cancer treatments including CD19.CAR-T cell therapy) and immune effector cell therapy associated neurotoxicity (ICANS, neurologic complications related to an activated immune system seen with immunotherapy and CD19.CAR-T cell therapy). Siltuximab is a chimeric (having parts of different origins) murine (from mice) antibody that binds directly to IL-6 (a cytokine/ body chemical causing toxicities) and allows for its clearance. IL-6 is known to increase in a patient's blood after CD19.CAR-T cell infusion and has been associated with development of CRS and ICANS. Giving siltuximab prior to CD19.CAR-T cell therapy may help reduce CRS and/or ICANS after therapy.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- BIOLOGICAL Siltuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05665725
The ClinicalTrials.gov registry entry for NCT05665725 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Timothy Voorhees, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05665725 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05665725 about?
NCT05665725 is a clinical study titled "Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma". This phase I trial tests the safety and side effects of siltuximab in preventing CAR T cell therapy related cytokine release syndrome in patients with CD19 positive non-Hodgkin lymphoma. Several of the major complications of CD19 directed chimeric antigen receptor T-cell therapy (CD19.CAR-T) include...
What is the current status of trial NCT05665725?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2023-01-31. Estimated completion is 2024-09-06.
What interventions are being tested in trial NCT05665725?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Siltuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05665725?
This trial is sponsored by Timothy Voorhees, which has 3 total clinical trials registered on ClinicalTrials.gov.
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