Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Elios Therapeutics, LLC
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.
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.
14578How 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.
35678What 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.
23578Eligibility 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
I am 18 years old or older.
I can undergo a procedure to provide enough tissue for a cancer vaccine.
I am fully active or can carry out light work.
I do not have any severe health issues that are not under control.
I do not have any current infections.
Exclusion Criteria
My cancer is quickly getting worse.
I have had or am expected to have an organ or stem-cell transplant.
I have been diagnosed with an immune system disorder.
I haven't had serious heart or stroke issues in the last 6 months.
I do not have any significant infections, including Hepatitis or HIV.
I haven't taken steroids, immunosuppressants, or chemotherapy in the last 30 days.
I need assistance with my daily activities.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment - Investigational ProductExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Southside Medical CenterGreenville, SC
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Who is running the clinical trial?
Elios Therapeutics, LLCLead Sponsor
LumaBridgeCollaborator
LumaBridgeIndustry Sponsor
References
Vaccination with melanoma lysate-pulsed dendritic cells, of patients with advanced colorectal carcinoma: report from a phase I study. [2020]Immune therapy have shown new and exciting perspectives for cancer treatment. Aim of our study was to evaluate toxicity and possible adverse effects from vaccination of patients with advanced colorectal cancer with autologous dendritic cells (DC) pulsed with lysate from a newly developed melanoma cell line, DDM-1.13. Six patients were enrolled in the phase I trial. Autologous DCs were generated in vitro from peripheral blood monocytes in the presence of granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4). DCs were pulsed with melanoma cell lysate from a cloned and selected melanoma cell line enriched in expression of MAGE-A antigens and deficient in expression of melanoma differentiation antigens: tyrosinase, MART-1 and gp100. Vaccinations were administered intradermally on the proximal thigh with a total of five given vaccines at 2 weeks intervals. Each vaccine contained 3-5 x 10(6) DCs. Five of the six patients received all five vaccines. The treatment was well tolerated in all patients without any observed vaccine-correlated adverse effects. Treatment with this DC-based cancer vaccine proved safe and non-toxic.
Randomized clinical studies of anti-tumor vaccination: state of the art in 2008. [2022]This review elucidates state-of-the-art clinical studies on active specific immunotherapy with tumor vaccines. It refers solely to randomized studies and has a special focus on patient's survival, the most important parameter for any therapy. Of special interest, from a tumor immunological point of view, is a comparison between the results obtained with allogeneic tumor cell-derived vaccines and those obtained with autologous tumor cell-derived vaccines. Overall, autologous vaccines have given better results than allogeneic vaccines. Random mutations in cancer generate unique antigens in each individual case. The superiority of autologous vaccines suggests that unique tumor-associated antigens are particularly important in generating responsive T cells for a therapeutic effect.
Tumor lysate-loaded biodegradable microparticles as cancer vaccines. [2021]Cancer vaccines that use tumor lysate (TL) as a source of tumor-associated antigens (TAAs) have significant potential for generating therapeutic anti-tumor immune responses. Vaccines encompassing TL bypass the limitations of single antigen vaccines by simultaneously stimulating immunity against multiple TAAs, thereby broadening the repertoire of TAA-specific T-cell clones available for activation. Administration of TL in particulate form, such as when encapsulated in biodegradable microparticles, increases its immunostimulatory capacity and produces more robust immune responses than when TL is given in soluble form. These effects can be further enhanced by co-administering TL with adjuvants. A number of recent studies using polymeric microparticle delivery of TL, with or without adjuvants, have produced promising results in preclinical studies. In this review, we will discuss current experimental approaches involving TL being pursued in the oncoimmunology field, and comment on strategies such as combining specific chemotherapeutic agents with TL microparticle delivery that may eventually lead to improved survival outcomes for cancer patients.
Shikonin-enhanced cell immunogenicity of tumor vaccine is mediated by the differential effects of DAMP components. [2021]The tumor cell lysate-pulsed, dendritic cell (DC)-based cancer vaccine approaches are being actively evaluated for application to cancer immunotherapy, hopefully at a personalized medicine base. There is apparently an emerging technical problem however, the lack of highly efficacious potency in activation of patient's DCs for T-cell priming and the associated process for presenting tumor immunogenicity.
Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors. [2018]Tumor vaccines use various strategies to generate immune responses, commonly targeting generic tumor-associated antigens. The tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from DC loaded with autologous tumor antigens, creating a patient-specific vaccine. Here, we describe initial phase I/IIa trial results.
PEGylated tumor cell membrane vesicles as a new vaccine platform for cancer immunotherapy. [2021]Despite the promise and advantages of autologous cancer cell vaccination, it remains challenging to induce potent anti-tumor immune responses with traditional immunization strategies with whole tumor cell lysate. In this study, we sought to develop a simple and effective approach for therapeutic vaccination with autologous whole tumor cell lysate. Endogenous cell membranes harvested from cancer cells were formed into PEGylated nano-vesicles (PEG-NPs). PEG-NPs exhibited good serum stability in vitro and draining efficiency to local lymph nodes upon subcutaneous administration in vivo. Vaccination with PEG-NPs synthesized from murine melanoma cells elicited 3.7-fold greater antigen-specific cytotoxic CD8+ T lymphocyte responses, compared with standard vaccination with freeze-thawed lysate in tumor-bearing mice. Importantly, in combination with anti-programmed death-1 (αPD-1) IgG immunotherapy, PEG-NP vaccination induced 4.2-fold higher frequency of antigen-specific T cell responses (P < 0.0001) and mediated complete tumor regression in 63% of tumor-bearing animals (P < 0.01), compared with FT lysate + αPD-1 treatment that exhibited only 13% response rate. In addition, PEG-NPs + αPD-1 IgG combination immunotherapy protected all survivors against a subsequent tumor cell re-challenge. These results demonstrate a general strategy for eliciting anti-tumor immunity using endogenous cancer cell membranes formulated into stable vaccine nanoparticles.
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]Immunotherapy has revolutionized the treatment of melanoma, yet survival remains poor for patients with metastatic disease. The autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine has been shown to be safe adjuvant therapy for patients with resected stage III/IV melanoma who complete the primary vaccine series. Here, we describe an open-label trial of patients with metastatic melanoma treated with TLPLDC vaccine in addition to standard of care (SoC) therapies. The TLPLDC vaccine is created by loading autologous tumor lysate into yeast cell wall particles, which are phagocytosed by autologous dendritic cells ex vivo. Patients who recurred while enrolled in a phase IIb trial of adjuvant TLPLDC vaccine (crossover cohort) and patients with measurable metastatic melanoma cohort were offered TLPLDC vaccine along with SoC therapies. Tumor response was measured by RECIST 1.1 criteria. Overall survival (OS) and progression-free survival (PFS) were estimated by intention-to-treat analysis. Fifty-four patients were enrolled (28 in crossover cohort; 26 in metastatic melanoma cohort). The vaccine was well-tolerated with no grade ≥3 adverse events when given with SoC therapies to include checkpoint inhibitors, BRAF/MEK inhibitors, tyrosine kinase inhibitors, intralesional therapy and/or radiation. In the crossover arm, OS was 76.5% and PFS was 57.1% (median follow-up of 13.9 months). In the metastatic melanoma arm, OS was 85.7% and PFS was 52.2% (median follow-up 8.5 months). The TLPLDC vaccine is well-tolerated and safe in combination with SoC therapies. Future trials will determine the efficacy of TLPLDC in combination with SoC therapies in metastatic melanoma.
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]The tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is made by ex vivo priming matured autologous dendritic cells (DCs) with yeast cell wall particles (YCWPs) loaded with autologous tumor lysate (TL). The tumor lysate, particle only (TLPO) vaccine uses autologous TL-loaded YCWPs coated with silicate for in vivo DC loading. Here we report the 36-month prespecified analyses of this prospective, randomized, double-blind trial investigating the ability of the TLPO and TLPLDC (±granulocyte-colony stimulating factor (G-CSF)) vaccines to prevent melanoma recurrence in high-risk patients.