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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: Completed Phase 1 study, sponsored by Timothy Voorhees.
NCT05665725 is a Phase 1 study that has completed, run by Timothy Voorhees. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events (AEs) will be described and classified per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events. The AE data associated with prophylaxis will be summarize for every patient: for patients receiving siltuximab only as prophylaxi
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 |
What the finished NCT05665725 record still lists
NCT05665725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05665725 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05665725's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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