TLPO Vaccine for Cancer

Overseen By Pauline Nichols, PA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Elios Therapeutics, LLC

Must not be taking: Steroids, Immunosuppressants, Chemotherapy

Disqualifiers: Pregnancy, Brain metastases, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer vaccine called TLPO (Autologous Tumor Lysate Particle Only Vaccine) for individuals with solid tumor cancers. The researchers aim to determine if the vaccine can delay cancer recurrence or progression, improve survival rates, and trigger an immune response. They also focus on assessing the vaccine's safety. Suitable candidates have solid tumor cancers, have completed standard cancer treatments, and have no severe or uncontrolled health issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take steroids, immunosuppressive therapy, or cytotoxic chemotherapy within 30 days of enrolling in the trial.

Is there any evidence suggesting that the TLPO vaccine is likely to be safe for humans?

Research has shown that the autologous TLPO vaccine is safe for people with solid tumors. Studies have found that vaccines like TLPO, made from a person's own tumor cells, are usually well-tolerated, meaning most people do not experience severe side effects.

In earlier studies, patients who received similar vaccines did not report major negative reactions, suggesting that the TLPO vaccine might be well-tolerated by most people. However, like any treatment, some side effects can occur, and these are being closely monitored to ensure safety.

The TLPO vaccine is currently in Phase 2 trials, which assess the treatment's safety and effectiveness. While early results are promising, ongoing research will provide more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often involve chemotherapy and radiation, the TLPO vaccine is unique because it harnesses the body's immune system to fight cancer. This vaccine uses autologous tumor lysate-loaded, yeast cell wall particles to train the immune system specifically against cancer cells, offering a personalized approach to treatment. Administered through intradermal injections, it could provide a more targeted and potentially less toxic option. Researchers are excited because this method may lead to more effective and longer-lasting cancer control with fewer side effects compared to traditional treatments.

What evidence suggests that the TLPO vaccine might be an effective treatment for solid tumor malignancies?

Research has shown that the TLPO vaccine, which participants in this trial will receive, might help treat solid tumor cancers. Studies have found that it can extend the time patients live without cancer recurrence and improve overall survival rates. Specifically, TLPO has been associated with fewer recurrences of melanoma, a type of skin cancer. The vaccine uses a mixture from broken-down cancer cells to help the immune system recognize and attack cancer cells. Early results suggest that TLPO can trigger a strong immune response, offering hope for better outcomes in various cancers. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with various types of solid tumor cancers, including those that have spread (metastasized). Participants must meet certain health standards but specific inclusion criteria are not listed. People who do not meet the study's requirements or have conditions that might interfere with the vaccine's effects will be excluded.

Inclusion Criteria

AST and ALT ≤2.5 × ULN, or ≤5 × ULN if due to liver involvement by tumor

Hemoglobin ≥9.0 g/dL

Patient must have the following laboratory values (obtained ≤28 days prior to enrollment):

Exclusion Criteria

My cancer is quickly getting worse.

I have been diagnosed with an immune system disorder.

I haven't had serious heart or stroke issues in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Procurement

Eligible patients undergo surgical resection or core needle biopsy for tissue procurement

1-2 weeks

Vaccine Preparation

Tumor samples are shipped for vaccine preparation and returned as TLPO vaccine

4 weeks

Vaccination

Participants receive intradermal injections of TLPO vaccine at 0, 1, and 2 months, followed by boosters at 6, 9, and 12 months

12 months

6 visits (in-person)

Follow-up

Participants are monitored for safety, disease progression, and immune response

24 months

Minimum of 4 visits (in-person) every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous TLPO Vaccine

Trial Overview The TLPO vaccine, made from a patient's own tumor cells, is being tested to see if it can slow down cancer progression or recurrence and improve survival rates. The study also evaluates safety based on standard criteria and checks whether the vaccine triggers an immune response against cancer.

How Is the Trial Designed?

Group I: Treatment - Investigational Product Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Elios Therapeutics, LLC

Lead Sponsor

Trials

3

Recruited

310+

LumaBridge

Collaborator

Trials

6

Recruited

410+

LumaBridge

Industry Sponsor

Trials

5

Recruited

380+

Published Research Related to This Trial

Cancer vaccines using tumor lysate (TL) can stimulate immune responses against multiple tumor-associated antigens (TAAs), making them potentially more effective than single antigen vaccines.

Encapsulating TL in biodegradable microparticles enhances its immunostimulatory effects, leading to stronger immune responses, especially when combined with adjuvants, which could improve survival outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor lysate-loaded biodegradable microparticles as cancer vaccines. Joshi, VB., Geary, SM., Gross, BP., et al.[2021]

The TLPLDC vaccine, which is personalized and made from a patient's own tumor antigens, showed a 39% clinical benefit rate in late-stage cancer patients, with some achieving complete or partial responses.

The vaccine was found to be safe, with mostly mild side effects (grade 0-2 toxicities), and 46% of late-stage patients remained disease-free at a median follow-up of 22.5 months, indicating its potential effectiveness and warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors. Herbert, GS., Vreeland, TJ., Clifton, GT., et al.[2018]

In a phase I trial involving six patients with advanced colorectal cancer, a vaccine using autologous dendritic cells pulsed with melanoma cell lysate was found to be safe and well tolerated, with no observed adverse effects.

The study demonstrated that the DC-based cancer vaccine, administered intradermally in five doses over ten weeks, did not cause any toxicity, suggesting a promising approach for immunotherapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination with melanoma lysate-pulsed dendritic cells, of patients with advanced colorectal carcinoma: report from a phase I study. Burgdorf, SK., Fischer, A., Claesson, MH., et al.[2020]

The study developed PEGylated nano-vesicles from autologous cancer cell membranes, which significantly enhanced immune responses, showing a 3.7-fold increase in cytotoxic CD8+ T lymphocyte responses compared to traditional whole tumor cell lysate vaccination.

When combined with anti-PD-1 immunotherapy, the PEG-NP vaccination led to a remarkable 63% complete tumor regression in treated mice, compared to only 13% with the standard treatment, indicating a potent synergistic effect in inducing anti-tumor immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PEGylated tumor cell membrane vesicles as a new vaccine platform for cancer immunotherapy. Ochyl, LJ., Bazzill, JD., Park, C., et al.[2021]

Autologous tumor cell-derived vaccines have shown better survival outcomes in patients compared to allogeneic tumor cell-derived vaccines, based on a review of randomized clinical studies.

The effectiveness of autologous vaccines may be attributed to their ability to target unique tumor-associated antigens, which are crucial for activating T cells and eliciting a therapeutic response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical studies of anti-tumor vaccination: state of the art in 2008. Fournier, P., Schirrmacher, V.[2022]

The TLPLDC vaccine, which uses autologous tumor lysate loaded into yeast particles, was found to be safe and well-tolerated when combined with standard of care therapies for metastatic melanoma, with no severe adverse events reported.

In a trial involving 54 patients, the overall survival rates were promising, with 76.5% in the crossover cohort and 85.7% in the metastatic melanoma cohort, suggesting potential benefits of the TLPLDC vaccine in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of autologous tumor lysate particle-loaded dendritic cell vaccination in combination with systemic therapies in patients with recurrent and metastatic melanoma. Adams, AM., Chick, RC., Vreeland, TJ., et al.[2023]

The TLPLDC and TLPO vaccines significantly improved disease-free survival (DFS) and overall survival (OS) in high-risk melanoma patients, with DFS rates of 55.4% for TLPLDC and 60.9% for TLPO compared to 27.2% for placebo.

The TLPLDC vaccine showed a favorable safety profile, with only two patients experiencing serious adverse events, indicating that these vaccines are not only effective but also safe for use in preventing melanoma recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis. Carpenter, EL., Van Decar, S., Adams, AM., et al.[2023]

The study found that the phytochemical shikonin (SK) enhances the immunogenicity of tumor cell lysates, leading to improved activation of dendritic cells (DCs) and stronger anti-tumor responses in mice.

Among the damage-associated molecular patterns (DAMPs) tested, HSP70 was identified as the most crucial component for activating DCs and promoting T cell proliferation, suggesting its potential as a key target for enhancing cancer vaccine efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shikonin-enhanced cell immunogenicity of tumor vaccine is mediated by the differential effects of DAMP components. Lin, TJ., Lin, HT., Chang, WT., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468294224000558

Tumor lysate particle only vaccine (TLPO) vs. ... TLPLDC has been shown to decrease recurrence in resected Stage III/IV melanoma patients in a Phase IIb trial. The TL particle only (TLPO) vaccine is produced by ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39305541/

Tumor lysate particle only vaccine (TLPO) vs. ... TLPLDC has been shown to decrease recurrence in resected Stage III/IV melanoma patients in a Phase IIb trial. The TL particle only (TLPO) vaccine is produced by ...

3. jitc.bmj.com jitc.bmj.com/content/9/Suppl_2/A571

542 Randomized trial of tumor lysate particle only vaccine ... Conclusions The TLPO and TLPLDC (without G-CSF) vaccines improved 36-month DFS and OS in this randomized phase 2 trial. The efficacy of the TLPO and TLPLDC ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10401209/

Prospective, randomized, double-blind phase 2B trial of the ... The TLPO and TLPLDC (without G-CSF) vaccines were associated with improved DFS and OS in this clinical trial. Given production and manufacturing ...

5. clinicaltrial.be clinicaltrial.be/en/details/419366?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Autologous TLPO Vaccine Basket A Prospective, Open-Label, All-Comers Phase IIa Trial of The Tumor Lysate, Particle Only (TLPO) Cancer Vaccine in Solid Tumor Malignancies.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06175221/autologous-tlpo-vaccine-basket

Autologous TLPO Vaccine Basket | Clinical Research Trial ... The goal of this clinical trial is to learn about TLPO cancer vaccine in cases of solid tumor malignancies.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02301611

NCT02301611 | Phase IIB TL + YCWP + DC in Melanoma We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine.