Status:
TERMINATED
Autologous TLPO Vaccine Basket
Lead Sponsor:
Elios Therapeutics, LLC
Collaborating Sponsors:
LumaBridge
Conditions:
Tumor, Solid
Tumor Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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/recurrenc...
Detailed 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. Enr...
Eligibility Criteria
Inclusion
- 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).
- Completion of standard adjuvant therapy to include chemotherapy, radiation therapy, and/or other immunosuppressive therapy as clinically indicated.
- Women of childbearing potential (WOCBP) and males with female partners of child- bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last inoculation.
- Patient must have a site of disease with planned incisional or excisional procedure expected to result in sufficient tissue for vaccine creation, or must be amenable to biopsy and be a candidate for tumor biopsy with anticipated sufficient tumor tissue resulting to vaccine creation.
Exclusion
- 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.
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06175221
Start Date
November 29 2023
End Date
July 2 2025
Last Update
September 15 2025
Active Locations (1)
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1
Southside Medical Center
Greenville, South Carolina, United States, 29615