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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

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.

Tumor lysate, particle only (TLPO) vaccine

Pauline Nichols, PA

Thaer Joudeh

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.

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.

Prospective, Open Label, All Comers, Single Arm Study.

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

Blood samples collected during the trial will be analyzed for the presence or absence of immunologic response markers.

To determine the disease control rate after vaccination.

To determine the objective response rate after vaccination.

To determine the duration of response after vaccination.

To determine time to progression per RECIST criteria after inoculation with the TLPO vaccine.

Treatment-related adverse events per CTCAE v5.0 will be analyzed to determine to safety and tolerability of the vaccine.

The time from inoculation to time of death will be recorded and OS rate will be calculated.

Spots Global Cancer Trial Database for elios

Every month we try and update this database with for elios cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for elios

Every month we try and update this database with for elios cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for elios cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.