Tumor, SolidPhase 2NCT06175221
Autologous TLPO Vaccine Basket
A Phase 2 study testing Tumor lysate, particle only (TLPO) vaccine in people with Tumor, Solid and Tumor Metastasis, run by Elios Therapeutics, LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about TLPO cancer vaccine in cases of solid tumor malignancies. The main objectives it aims to learn about are: What is the time to progression/recurrence of disease after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies? What is the overall… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid, Tumor Metastasis, Cancer
- What is being tested?
- Tumor lysate, particle only (TLPO) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 2 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be ≥18 years of age.
- Stage I-IV patients.
- Demonstrated tolerance of maintenance or adjuvant immunotherapy, targeted therapy, and/or hormonal therapy for three doses (if maintenance therapy is indicated)
- ECOG 0-1 performance.
- Patient must have a predicted life expectancy of ≥ 6 months.
- No uncontrolled or life-threatening health conditions.
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- No active, acute infections
- Patient must have the following laboratory values (obtained ≤28 days prior to enrollment):
- Serum creatinine <2 × upper limit of normal (ULN) or if higher than normal range, calculated creatinine clearance (CrCL) must be ≥30 mL/min/1.73 m2; actual body weight must be used for CrCL unless BMI >30 kg/m2 then lean body weight must be used.
- Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN).
- AST and ALT ≤2.5 × ULN, or ≤5 × ULN if due to liver involvement by tumor.
- Hemoglobin ≥9.0 g/dL.
- Platelets ≥100 × 109 cells/L.
- Absolute neutrophil count ≥1.5 ×109 cells/L (without the use of hematopoietic growth factors).
- Corrected QT interval (QTc) <470 ms for females and <450 ms for males (as calculated by the Fridericia correction formula).
- Completion of standard adjuvant therapy to include chemotherapy, radiation therapy, and/or other immunosuppressive therapy as clinically indicated.
- Women of childbearing potential (WOCBP) and males with female partners of child- bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last inoculation.
- Patient must have a site of disease with planned incisional or excisional procedure expected to result in sufficient tissue for vaccine creation, or must be amenable to biopsy and be a candidate for tumor biopsy with anticipated sufficient tumor tissue resulting to vaccine creation.
Who cannot join
- Steroids, immunosuppressive therapy (to include mTOR inhibitors), or cytotoxic chemotherapy within 30 days of enrollment.
- Involved in other clinical trials.
- ECOG ≥2
- Pregnancy and/or breast feeding.
- Untreated or progressing brain metastases. Treated stable brain metastases that have not progressed for at least 3 months will be permitted at the PI's discretion.
- Rapidly progressive disease or visceral crisis
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- Patient has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time
- Patient has a diagnosis of immunodeficiency, either primary or acquired.
- Patient has current second malignancy at other sites (exceptions: nonmelanomatous skin cancer, adequately treated in situ carcinoma [e.g., cervical], or indolent prostate cancer under observation). A history of other malignancies is allowed as long as patient has been free of recurrence for ≥2 years, or if the patient has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence.
- Patient has active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or HIV (testing not required).
- Patient has received live vaccines within the past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date >30 days prior to administration of TLPO).
- History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
- Patient has any medical or social condition that, in the opinion of the Investigator, might place a patient at increased risk, affect compliance, or confound safety or other clinical study data interpretation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southside Medical Center
Greenville, South Carolina, 29615
About this study
Official title: A Prospective, Open-Label, All-Comers Phase IIa Trial of The Tumor Lysate, Particle Only (TLPO) Cancer Vaccine in Solid Tumor Malignancies
The goal of this clinical trial is to learn about TLPO cancer vaccine in cases of solid tumor malignancies. The main objectives it aims to learn about are:
- What is the time to progression/recurrence of disease after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies?
- What is the overall survival after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies?
- What are the safety characteristics of autologous TLPO using standardized criteria (Common Terminology Criteria for Adverse Events v5.0)
- Does TPLO generate an immune response?
- Determine the presence, rate, and duration of any disease control response affected by TPLO.
Read the detailed description
Patients with any stage solid tumor malignancy will be identified and screened for study inclusion and exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. Enrolled patients will undergo either surgical resection or core needle biopsy of their tumor, with a minimum of 1mg of tumor sterilely frozen. This tumor sample will be shipped via FedEx to our central facility in Greenville, SC, for vaccine preparation.
As indicated by standard treatments determined by the treating team, if a patient will require systemic therapy such as cytotoxic chemotherapy and/or radiation therapy, vaccination with the TLPO vaccine will not begin until after such treatments have been completed. However, patients on maintenance non-immunosuppressive therapy to include targeted therapy, immunotherapy including checkpoint inhibitors, and/or hormonal therapy may start the vaccine trial after demonstrating tolerance of these therapies for three months prior to first inoculation.23 Vaccines will be produced by loading TL into pre-prepared YCWP, as a single dose vial of 1.0 x 108 TLPO, and then labeled with the patient's unique study number. The TLPO vaccine will then be sent back to the site. The site will receive six single dose vials to be injected intradermally at 0, 1, and 2 months followed by boosters at 6, 9, and 12 months in the same lymph node draining area, preferably the anterior thigh. Safety data will be collected for any local or systemic toxicity. Safety data will be graded and reported per CTCAE v5.0. Time to progression and additional study endpoints will be monitored as guided for current standard treatments by NCCN. Participants will be followed by their treatment team at a minimum of once every six months for the two-year study period. If the treatment team suspects recurrence by either symptoms, imaging, or other means, biopsy and pathologic confirmation will be obtained. Time to recurrence will be based on time from initial inoculation of vaccine to time of confirmed recurrence. Overall survival will be based on time from initial inoculation of the vaccine to time of death. Patients will be treated by current standard therapies for their recurrence. Safety and tumor response will be assessed per RECIST and iRECIST on their standard follow-up scans.
Blood (50cc) will be collected from patients prior to each inoculation for immunologic testing of the patient's T-cell response and/or future scientific purposes.
- Conditions
- Tumor, Solid, Tumor Metastasis, Cancer, Tumor
- Being tested
- Tumor lysate, particle only (TLPO) vaccine
- Keywords
- TLPO, Elios, Solid Tumor Malignancies, TLPLDC, Cancer Vaccine, Tumor, Cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor lysate, particle only (TLPO) vaccineBiological
Also called TLPO
A novel technology in which a patient's tumor lysate (TL) is loaded into microparticles for DC phagocytosis and antigen processing allows for vaccine efficacy, while minimizing tissue demands by only requiring approximately 250-500ug of tumor. Immature DCs avidly phagocytose small particles in the range of 1-5 microns. Tumor tissue collected from the patient undergoes a process of freeze-thaw cycling to create a TL suspension. The microparticles, yeast-cell wall particles (YCWP), are created from Saccharomyces cerevisiae by NaOH/HCl digestion of all non-cell wall components and washed, producing β-glycan shells. The TL is then loaded into these YCWP.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Investigational Product | Experimental | Product Name: Tumor lysate, particle only (TLPO) vaccine
Dosage Form: Intradermal Injection
Unit Dose: 1x10^8 autologous tumor lysate-loaded, yeast cell wall particles
Route of Administration: Intradermal; primary vaccine series at 0, 1, 2 months followed by boosters at 6, 9, and 12 months
Physical Description: 250 uL clear liquid vials
Manufacturer: Elios Therapeutics, LLC Receives: Biological: Tumor lysate, particle only (TLPO) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
To determine time to progression per RECIST criteria after inoculation with the TLPO vaccine.
Measured: 24 months
Secondary outcomes (2)
Number of participants with treatment-related adverse events per CTCAE v5.0
Treatment-related adverse events per CTCAE v5.0 will be analyzed to determine to safety and tolerability of the vaccine.
Measured: 24 months
Overall survival (OS) after vaccination
The time from inoculation to time of death will be recorded and OS rate will be calculated.
Measured: Time from inoculation to time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start29 Nov 2023
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Open Label, All Comers, Single Arm Study.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elios Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LumaBridge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175221
- Sponsor's protocol ID
- ET-Bas-002
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, All-Comers Phase IIa Trial of The Tumor Lysate, Particle Only (TLPO) Cancer Vaccine in Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT06175221
- Acronym / sponsor ID
- ET-Bas-002
- Conditions
- Tumor, Solid, Tumor Metastasis, Cancer, Tumor
- Keywords
- TLPO, Elios, Solid Tumor Malignancies, TLPLDC, Cancer Vaccine, Tumor, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Elios Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- LumaBridge
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about TLPO cancer vaccine in cases of solid tumor malignancies. The main objectives it aims to learn about are:
- What is the time to progression/recurrence of disease after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies?
- What is the overall survival after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies?
- What are the safety characteristics of autologous TLPO using standardized criteria (Common Terminology Criteria for Adverse Events v5.0)
- Does TPLO generate an immune response?
- Determine the presence, rate, and duration of any disease control response affected by TPLO.
Detailed description
Patients with any stage solid tumor malignancy will be identified and screened for study inclusion and exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. Enrolled patients will undergo either surgical resection or core needle biopsy of their tumor, with a minimum of 1mg of tumor sterilely frozen. This tumor sample will be shipped via FedEx to our central facility in Greenville, SC, for vaccine preparation.
As indicated by standard treatments determined by the treating team, if a patient will require systemic therapy such as cytotoxic chemotherapy and/or radiation therapy, vaccination with the TLPO vaccine will not begin until after such treatments have been completed. However, patients on maintenance non-immunosuppressive therapy to include targeted therapy, immunotherapy including checkpoint inhibitors, and/or hormonal therapy may start the vaccine trial after demonstrating tolerance of these therapies for three months prior to first inoculation.23 Vaccines will be produced by loading TL into pre-prepared YCWP, as a single dose vial of 1.0 x 108 TLPO, and then labeled with the patient's unique study number. The TLPO vaccine will then be sent back to the site. The site will receive six single dose vials to be injected intradermally at 0, 1, and 2 months followed by boosters at 6, 9, and 12 months in the same lymph node draining area, preferably the anterior thigh. Safety data will be collected for any local or systemic toxicity. Safety data will be graded and reported per CTCAE v5.0. Time to progression and additional study endpoints will be monitored as guided for current standard treatments by NCCN. Participants will be followed by their treatment team at a minimum of once every six months for the two-year study period. If the treatment team suspects recurrence by either symptoms, imaging, or other means, biopsy and pathologic confirmation will be obtained. Time to recurrence will be based on time from initial inoculation of vaccine to time of confirmed recurrence. Overall survival will be based on time from initial inoculation of the vaccine to time of death. Patients will be treated by current standard therapies for their recurrence. Safety and tumor response will be assessed per RECIST and iRECIST on their standard follow-up scans.
Blood (50cc) will be collected from patients prior to each inoculation for immunologic testing of the patient's T-cell response and/or future scientific purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Open Label, All Comers, Single Arm Study.
| Arm | Type | Receives |
|---|---|---|
| Treatment - Investigational Product | Experimental | Biological: Tumor lysate, particle only (TLPO) vaccineProduct Name: Tumor lysate, particle only (TLPO) vaccine Dosage Form: Intradermal Injection Unit Dose: 1x10^8 autologous tumor lysate-loaded, yeast cell wall particles Route of Administration: Intradermal; primary vaccine series at 0, 1, 2 months followed by boosters at 6, 9, and 12 months Physical Description: 250 uL clear liquid vials Manufacturer: Elios Therapeutics, LLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient must be ≥18 years of age.
- Stage I-IV patients.
- Demonstrated tolerance of maintenance or adjuvant immunotherapy, targeted therapy, and/or hormonal therapy for three doses (if maintenance therapy is indicated)
- ECOG 0-1 performance.
- Patient must have a predicted life expectancy of ≥ 6 months.
Key exclusion criteria (13 listed)
- Steroids, immunosuppressive therapy (to include mTOR inhibitors), or cytotoxic chemotherapy within 30 days of enrollment.
- Involved in other clinical trials.
- ECOG ≥2
- Pregnancy and/or breast feeding.
- Untreated or progressing brain metastases. Treated stable brain metastases that have not progressed for at least 3 months will be permitted at the PI's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor lysate, particle only (TLPO) vaccineAlso: TLPOA novel technology in which a patient's tumor lysate (TL) is loaded into microparticles for DC phagocytosis and antigen processing allows for vaccine efficacy, while minimizing tissue demands by only requiring approximately 250-500ug of tumor. Immature DCs avidly phagocytose small particles in the range of 1-5 microns. Tumor tissue collected from the patient undergoes a process of freeze-thaw cycling to create a TL suspension. The microparticles, yeast-cell wall particles (YCWP), are created from Saccharomyces cerevisiae by NaOH/HCl digestion of all non-cell wall components and washed, producing β-glycan shells. The TL is then loaded into these YCWP. | Biological | Treatment - Investigational Product |
Primary outcome
Time to Disease Progression
Time frame: 24 months
To determine time to progression per RECIST criteria after inoculation with the TLPO vaccine.
2 secondary outcomes
Number of participants with treatment-related adverse events per CTCAE v5.0
Time frame: 24 months
Overall survival (OS) after vaccination
Time frame: Time from inoculation to time of death
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tumor lysate, particle only (TLPO) vaccine in people with Tumor, Solid and Tumor Metastasis, run by Elios Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.