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NCT03762291 · ClinicalTrials.gov registry record · Phase 1
Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03762291: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT03762291 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03762291, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Multiple myeloma patients will receive a cancer vaccine, called TXSVN that has been derived from the bacteria Salmonella. TXSVN is a weakened form of a live vaccine strain of the Salmonella bacteria (also known as the CVD908ssb strain) that has been genetically modified in the laboratory to produce a protein known as Survivin that stimulates an immune response in the body to the Survivin tumor antigen. CVD908ssb has been administered to over 80 healthy donors as a Salmonella vaccine in reported clinical trials. This trial intends to explore administration of this vaccine at a lower dose than what was tested in healthy individuals. Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin. TXSVN may activate the immune system which is your body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports. TXSVN, the modified strain of CVD908ssb has not been tested in humans to this date. TXSVN is an investigational product not approved by the U.S. Food and Drug Administration. The purpose of this study is to find the largest safe dose of TXSVN, to learn what the side effects are, and to see whether this therapy might help participants with multiple myeloma.
Primary Outcome
Incidence of dose limiting toxicities (DLT) of CVD908ssb-TXSVN vaccine in patients with multiple myeloma.
Interventions
- BIOLOGICAL CVD908ssb-TXSVN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2024-08-05 |
| Phase | Phase 1 |
What the finished NCT03762291 record still lists
NCT03762291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which CVD908ssb-TXSVN is the first listed.
NCT03762291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03762291 about?
NCT03762291 is a clinical study titled "Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine". Multiple myeloma patients will receive a cancer vaccine, called TXSVN that has been derived from the bacteria Salmonella. TXSVN is a weakened form of a live vaccine strain of the Salmonella bacteria (also known as the CVD908ssb strain) that has been genetically modified in the laboratory to produce ...
What is the current status of trial NCT03762291?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-08-06. Estimated completion is 2024-08-05.
What interventions are being tested in trial NCT03762291?
The interventions under investigation include: CVD908ssb-TXSVN (BIOLOGICAL).
Who is sponsoring clinical trial NCT03762291?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03762291's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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