TLPO Vaccine for Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Elios Therapeutics, LLC

Must not be taking: Steroids, Immunosuppressants, Chemotherapy

Disqualifiers: Pregnancy, Brain metastases, Immunodeficiency, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new cancer vaccine made from a patient's own tumor cells. It targets patients with solid tumors and aims to help their immune system fight the cancer. The vaccine works by teaching the immune system to recognize and attack cancer cells.

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.

What data supports the effectiveness of the TLPO Vaccine treatment for cancer?

The TLPO Vaccine, which uses tumor lysate (a mixture of proteins from a patient's own tumor) to stimulate the immune system, has shown promise in preventing melanoma recurrence in high-risk patients. Studies have indicated that similar vaccines, like the TLPLDC, are safe and can improve survival rates when combined with standard cancer treatments. ^{1 2 3 4 5}

Is the TLPO Vaccine safe for humans?

The TLPO Vaccine, also known as the TLPLDC vaccine, has been shown to be safe in clinical trials for patients with melanoma and other solid tumors, with no severe side effects reported. ^{3 4 5 6 7}

How is the TLPO Vaccine treatment different from other cancer treatments?

The TLPO Vaccine is unique because it uses a patient's own tumor material to create a personalized vaccine, which is then coated with silicate for direct delivery to the body's immune cells, potentially enhancing the immune response against cancer. ^{2 3 4 5 8}

Research Team

Eligibility Criteria

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

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Autologous TLPO Vaccine (Cancer 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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized clinical studies of anti-tumor vaccination: state of the art in 2008. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Tumor lysate-loaded biodegradable microparticles as cancer vaccines. [2021]

3. Netherlands 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. [2018]

4. England 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. [2023]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Vaccination with melanoma lysate-pulsed dendritic cells, of patients with advanced colorectal carcinoma: report from a phase I study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Shikonin-enhanced cell immunogenicity of tumor vaccine is mediated by the differential effects of DAMP components. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

PEGylated tumor cell membrane vesicles as a new vaccine platform for cancer immunotherapy. [2021]