Yeast vaccine shows promise in stopping Cancer's return
NCT ID NCT03552718
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a custom-made yeast vaccine designed to train the immune system to recognize and attack leftover cancer cells. Five adults with various cancers (like colorectal, breast, or lung) who had completed initial treatment received the vaccine. The goal was to see if it was safe and could help prevent the cancer from coming back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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5 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Pre-treatment Phase: Tissue Procurement and Development of Vaccine 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines. 3. Histologically-confirmed cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling. * Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple-negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines. 4. Must be willing to agree to initiation of development of personalized YE-NEO-001 vaccine. Treatment Phase: 1. No evidence of disease (NED) at first assessment post multi-modality therapy (ie, surgery and/or radiation therapy and/or chemotherapy). Subjects treated with definitive radiation therapy are considered NED if they have no evidence of cancer growth on the first and second surveillance CT scans. Subjects who have disease recurrence prior to the start of the vaccination process are also eligible if no satisfactory alternative treatment options are available or if subject has refused all other available therapies. 2. Must have received \< 6 months of SoC therapy. 3. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines. 4. ECOG performance status of 0 to 2. 5. Must be willing to provide blood samples prior to the start of treatment on this study for exploratory analyses. 6. If cancer recurs while on treatment on this study, must be willing to provide a tumor biopsy specimen for exploratory analyses, if considered safe by the Investigator. 7. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 8. Agreement to practice effective contraception for female subjects with child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, and abstinence. Exclusion Criteria: Pre-treatment Phase: Tissue Procurement and Development of Vaccine 1\. Unable or unwilling to attend required study visits and return for adequate follow-up, as required by this protocol. Treatment Phase: 1. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications. 2. Active autoimmune disease requiring systemic immunosuppressive treatment within 4 weeks prior to enrollment on this study (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, ankylosing spondylitis, scleroderma, multiple sclerosis). A history of inactive autoimmune disease or autoimmune disease not requiring systemic immunosuppressive therapy within 4 weeks prior to study enrollment is allowed. 3. History of organ transplant requiring immunosuppression. 4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis). 5. Inadequate organ function, evidenced by the following laboratory results: 1. ANC \< 1,000 cells/mm\^3. 2. Platelet count \< 75,000 cells/mm\^3. 3. Uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL). 4. Total bilirubin \> ULN (unless the subject has documented Gilbert's syndrome). 5. AST (SGOT) or ALT (SGPT) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases). 6. Alkaline phosphatase levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \> 10 × ULN in subjects with bone metastases). 7. Serum creatinine \> 2.0 mg/dL or 177 μmol/L. 6. Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry. 7. Positive results of screening test for HIV. 8. Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed. 9. Known hypersensitivity to any component of the study medication(s). 10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with the study treatment. Anti-androgen and anti-estrogen medications are allowed. 11. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to initiation of treatment on this study, except for testosterone-lowering therapy in men with prostate cancer. 12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 13. Concurrent participation in any interventional clinical trial. 14. Pregnant and nursing women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245, United States
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