A Phase 1 interventional study of CVD908ssb-TXSVN in Multiple Myeloma, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Treatment
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.
The vaccine will be administered orally (by mouth) as a solution mixed with sodium bicarbonate. Approximately 10 minutes prior to receiving the vaccine, participants will take sodium bicarbonate pills to assist with the absorption of the vaccine. Participants may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the vaccine. Participants will remain in the clinic for three hours after receiving the vaccine for monitoring.Two doses of TXSVN will be given two weeks apart. Participants disease will be assessed pre-treatment and then 6 weeks after the second treatment. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital.
In between the first and second treatments, and for 6 weeks after the last treatment, the investigators ask that participants not receive any other anti-cancer treatments such as radiation therapy or chemotherapy. If participants do receive any other therapies in-between the first and second treatment, then they will be taken off treatment and will not be able to receive the second treatment of cells.
This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 3 different levels) of TXSVN. Once that dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side-effects are too severe, the dose will be lowered or the TXSVN administrations will be stopped.
Before being treated, participants will receive a series of standard medical tests:
Participants will receive standard medical tests when they are getting the vaccine and after:
To learn more about the way the vaccine is working in the participants body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each vaccination, and weekly for eight (8) weeks after the participants first vaccination.
Study Duration: The participants active participation in this study will last for approximately one (1) year. The investigators will then contact the participants once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate the participants disease response long-term. While participants are being followed on study, investigators will collect information about the response to the vaccine (how well or not the participants multiple myeloma responds to the treatment) and any toxicities the participants may experience. This study will continue until it has completed enrolling subjects and all subjects have completed follow-up or have come off study.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 1 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
3 different dosing schedules will be studied (3+3 design). At the beginning, patients will start on the lowest dose (1 of 3 different levels) of TXSVN. Once that dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side-effects are too severe, the dose will be lowered or the TXSVN administrations will be stopped. Each patient will receive 2 vaccinations at the same dose, 2 weeks apart, according to the following dosing schedules: The administration will be oral. Dose Level 1 Day 0: 2 x 10\^5 cfu Day 14: 2 x 10\^5 cfu Dose Level 2 Day 0: 2 x 10\^6 cfu Day 14: 2 x 10\^6 cfu Dose Level 3 Day 0: 2 x 10\^7 cfu Day 14: 2 x 10\^7 cfu
Biological: CVD908ssb-TXSVN
TXSVN may activate the immune system which is the participants 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. 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.
Also known as: TXSVN
Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0
Incidence of dose limiting toxicities (DLT) of CVD908ssb-TXSVN vaccine in patients with multiple myeloma.
Time frame: 8 weeks
Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
Overall response rate is defined as the proportion of subjects with best overall response of complete response (CR), stringent complete response (sCR), very good partial response (VGPR) or partial response (PR) according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
Time frame: 8 weeks
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine