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Cancer Vaccine
Salmonella-Based Cancer Vaccine for Multiple Myeloma (MAPSS Trial)
Phase 1
Waitlist Available
Led By Premal Lulla, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with bilirubin less than or equal to 2x upper limit of normal and Hgb greater than or equal to 7.0 (transfusion allowed)
Patients with a creatinine less than or equal to 2x upper limit of normal for age
Must not have
HIV infection
Grade II or higher nausea, vomiting or diarrhea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new cancer vaccine called TXSVN, made from a weakened Salmonella bacteria, in patients with multiple myeloma. The vaccine aims to boost the immune system to fight cancer cells by targeting a specific protein found in these cells. The study will determine the safest dose and monitor side effects and effectiveness.
Who is the study for?
This trial is for adults over 18 with multiple myeloma who've had at least two prior treatments, including possibly a stem cell transplant. They must be able to swallow medication, have decent organ function and blood counts, not be pregnant or breastfeeding, and agree to use effective birth control. Those with severe infections or on high-dose steroids can't join.
What is being tested?
The study tests TXSVN, an investigational cancer vaccine derived from genetically modified Salmonella that targets Survivin in cancer cells. It aims to find the highest safe dose of TXSVN, understand side effects, and assess its potential effectiveness against multiple myeloma.
What are the potential side effects?
Potential side effects are not fully known since this is the first time TXSVN is being tested in humans. However, based on similar vaccines' profiles, possible reactions may include flu-like symptoms such as fever and chills or gastrointestinal issues like nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bilirubin levels are normal or slightly high, and my hemoglobin is at least 7.0.
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My kidney function, measured by creatinine, is within twice the normal limit for my age.
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I am able to live my life with varying degrees of assistance.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am HIV positive.
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I experience moderate to severe nausea, vomiting, or diarrhea.
Select...
I cannot tolerate antibiotics for Salmonella.
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I am currently suffering from a severe infection.
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I am taking more than 0.5 mg/kg/day of steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0
Secondary study objectives
Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CVD908ssb-TXSVNExperimental Treatment1 Intervention
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Myeloma include immunotherapies, proteasome inhibitors, and monoclonal antibodies. Immunotherapies, such as the TXSVN cancer vaccine, work by stimulating the immune system to recognize and attack cancer cells expressing specific antigens like Survivin.
This is crucial for Multiple Myeloma patients as it offers a targeted approach to eliminate cancer cells while sparing normal cells, potentially reducing side effects. Proteasome inhibitors disrupt protein degradation in cancer cells, leading to cell death, while monoclonal antibodies target specific proteins on cancer cells to mark them for immune destruction.
These mechanisms are vital as they provide multiple avenues to combat the disease, improving patient outcomes and offering hope for long-term remission.
A pilot study of pembrolizumab in smoldering myeloma: report of the clinical, immune, and genomic analysis.Current vaccination strategies for the treatment of B-cell lymphoma and multiple myeloma.
A pilot study of pembrolizumab in smoldering myeloma: report of the clinical, immune, and genomic analysis.Current vaccination strategies for the treatment of B-cell lymphoma and multiple myeloma.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,494 Total Patients Enrolled
6 Trials studying Multiple Myeloma
876 Patients Enrolled for Multiple Myeloma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,854 Total Patients Enrolled
5 Trials studying Multiple Myeloma
147 Patients Enrolled for Multiple Myeloma
The Methodist Hospital Research InstituteOTHER
285 Previous Clinical Trials
81,685 Total Patients Enrolled
6 Trials studying Multiple Myeloma
189 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin levels are normal or slightly high, and my hemoglobin is at least 7.0.My kidney function, measured by creatinine, is within twice the normal limit for my age.People in your household who are pregnant, have a weak immune system, or are under 2 years old.I am HIV positive.I experience moderate to severe nausea, vomiting, or diarrhea.You had an allergic reaction to a Salmonella vaccine before.I am able to live my life with varying degrees of assistance.I cannot tolerate antibiotics for Salmonella.Your white blood cell count is higher than 1000 at the time of vaccination and your lymphocyte count is higher than 500.Your AST blood test result is not more than 3 times the normal limit.I can swallow pills.I am not pregnant and willing to use effective birth control or I have had a hysterectomy or tubal ligation.I am over 18, have Myeloma, and have tried at least two treatments or had a stem cell transplant over 90 days ago.My oxygen level is above 90% without extra oxygen, after chest radiation.I haven't taken any antibiotics for the last 14 days.I stopped my conventional therapy at least a week ago, except for immunomodulators.I am currently suffering from a severe infection.I am taking more than 0.5 mg/kg/day of steroids.
Research Study Groups:
This trial has the following groups:- Group 1: CVD908ssb-TXSVN
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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