Autologous TLPO Vaccine Basket

Cancer Clinical Trial

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

Status Recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis
• Neoplasms
• Tumor
• Tumor Metastasis
• Tumor, Solid

• NCT number: NCT06175221
• Study type: Interventional
• Source: Elios Therapeutics, LLC
• Contact: Pauline Nichols, PA
• Phone: 864-312-5156
• Email: pauline.nichol@eliosholdings.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 29, 2023
• Completion date: June 1, 2027