Autologous TLPO Vaccine Basket

NCT06175221 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: ET-Bas-002
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor, Solid; Tumor Metastasis; Cancer; Tumor

Keywords

TLPO; Elios; Solid Tumor Malignancies; TLPLDC; Cancer Vaccine; Tumor; Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression

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

  24 months

Secondary Outcomes (2)

• Number of participants with treatment-related adverse events per CTCAE v5.0

  24 months

• Overall survival (OS) after vaccination

  Time from inoculation to time of death

Other Outcomes (4)

• Immune Response after vaccination

  24 months

• Disease Control Rate

  24 months

• Objective Response Rate

  24 months

Study Arms (1)

Treatment - Investigational Product

EXPERIMENTAL

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

Biological: Tumor lysate, particle only (TLPO) vaccine

Interventions

Tumor lysate, particle only (TLPO) vaccine BIOLOGICAL

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.

Also known as: TLPO

Treatment - Investigational Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be ≥18 years of age.
• Stage I-IV patients.
• Demonstrated tolerance of maintenance or adjuvant immunotherapy, targeted therapy, and/or hormonal therapy for three doses (if maintenance therapy is indicated)
• ECOG 0-1 performance.
• Patient must have a predicted life expectancy of ≥ 6 months.
• No uncontrolled or life-threatening health conditions.
• No active, acute infections
• Patient must have the following laboratory values (obtained ≤28 days prior to enrollment):
• Serum creatinine \<2 × upper limit of normal (ULN) or if higher than normal range, calculated creatinine clearance (CrCL) must be ≥30 mL/min/1.73 m2; actual body weight must be used for CrCL unless BMI \>30 kg/m2 then lean body weight must be used.
• Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN).
• AST and ALT ≤2.5 × ULN, or ≤5 × ULN if due to liver involvement by tumor.
• Hemoglobin ≥9.0 g/dL.
• Platelets ≥100 × 109 cells/L.
• Absolute neutrophil count ≥1.5 ×109 cells/L (without the use of hematopoietic growth factors).
• Corrected QT interval (QTc) \<470 ms for females and \<450 ms for males (as calculated by the Fridericia correction formula).

You may not qualify if:

• Steroids, immunosuppressive therapy (to include mTOR inhibitors), or cytotoxic chemotherapy within 30 days of enrollment.
• Involved in other clinical trials.
• ECOG ≥2
• Pregnancy and/or breast feeding.
• Untreated or progressing brain metastases. Treated stable brain metastases that have not progressed for at least 3 months will be permitted at the PI's discretion.
• Rapidly progressive disease or visceral crisis
• Patient has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time
• Patient has a diagnosis of immunodeficiency, either primary or acquired.
• Patient has current second malignancy at other sites (exceptions: nonmelanomatous skin cancer, adequately treated in situ carcinoma \[e.g., cervical\], or indolent prostate cancer under observation). A history of other malignancies is allowed as long as patient has been free of recurrence for ≥2 years, or if the patient has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence.
• Patient has active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or HIV (testing not required).
• Patient has received live vaccines within the past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date \>30 days prior to administration of TLPO).
• History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of \>Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
• Patient has any medical or social condition that, in the opinion of the Investigator, might place a patient at increased risk, affect compliance, or confound safety or other clinical study data interpretation.

Sponsors & Collaborators

• Elios Therapeutics, LLC: lead
• LumaBridge: collaborator

Study Sites (1)

Southside Medical Center

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Open Label, All Comers, Single Arm Study.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2023
• Study Start: November 29, 2023
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)