NCT03762291CompletedPhase 1
Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine
Source: ClinicalTrials.gov · Last updated 5 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 11 Sept 2018
- Start date
- 6 Aug 2021
- Primary completion date
- 22 Mar 2022
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Multiple myeloma
- NCT number
- NCT03762291
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 1
- From 6 Aug 2021 to the primary completion date, 22 Mar 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving greater than 0.5 mg/kg/day (prednisone equivalent) of systemic corticosteroids
- History of allergy to prior vaccination with a Salmonella vaccine
Other illness
- Severe intercurrent infection.
- HIV infection
Age
- Household contacts who are immunocompromised, pregnant or under 2 years of age.
Other
- Pregnant or breast feeding.
- Grade II or higher nausea, vomiting or diarrhea.
- Unable to tolerate Salmonella directed antibiotics
Who the study is looking for
- Any patient, greater than or equal to 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least two lines of conventional therapy which can include an autologous HSCT. If a patient has received an autologous or syngeneic SCT they must be greater than 90 days post-transplant
- Patients with life expectancy greater than or equal to 6 weeks.
- Pulse oximetry of greater than 90% on room air in patients who previously received radiation therapy to the chest. This is not required in patients who have not received radiation therapy to the chest in the past.
- Patients with a Karnofsky score of greater than or equal to 50
- Patients with bilirubin less than or equal to 2x upper limit of normal and Hgb greater than or equal to 7.0 (transfusion allowed).
- AST less than or equal to 3x upper limit of normal.
- ANC greater than 1000 at the time of vaccination and an ALC greater than 500.
- Patients with a creatinine less than or equal to 2x upper limit of normal for age.
- Patients should have been off other investigational therapy for one month prior to entry in this study.
- Patients should be off anti-bacterial therapy for 14 days prior to vaccination
- Patients should have been off conventional therapy for at least 1 week prior to entry in this study except immunomodulator drugs
- Informed consent explained to, understood by and signed by patient. Patient given copy of informed consent.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
- Ability to swallow medications
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.