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ACTIVE NOT RECRUITING

NCT06614140

PHASE1/PHASE2

Personalized Neoantigen Cancer Vaccine for Patients with Solid Tumors

Sponsor: Seqker Biosciences, Inc.

View on ClinicalTrials.gov

Summary

This clinical trial aims to evaluate the safety, immunogenicity, and preliminary efficacy of a personalized neoantigen peptide vaccine in patients with advanced cancer or at high risk of recurrence. The study is designed for patients whose tumors have specific mutations identifiable through genomic sequencing. These mutations, known as neoantigens, are unique to each patient's cancer and serve as the target for the personalized vaccine. Eligible patients will undergo genomic analysis, including whole exome sequencing and RNA sequencing, to identify these neoantigens. A custom peptide vaccine will then be produced and formulated to target these neoantigens. The trial consists of a preparation phase, a treatment phase with priming and booster vaccinations, and a follow-up/maintenance period of one year. The study will assess immune responses, clinical efficacy, and potential toxicities. By leveraging the immune system's ability to recognize and attack cancer cells, this vaccine aims to provide a new treatment option for patients with limited alternatives.

Official title: A Phase I/IIb Study of Personalized Neoantigen Peptide-Based Cancer Vaccine for Patients with Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-11-24

Completion Date

2025-08-15

Last Updated

2024-09-26

Healthy Volunteers

Conditions

Cancer Solid Tumor, Adult

Interventions

BIOLOGICAL

Personalized Neoantigen Peptide Vaccine with Poly-ICLC and Checkpoint Inhibitors

This intervention involves a personalized neoantigen peptide vaccine composed of peptides containing tumor-specific mutations, such as SNVs, indels, and frameshift mutations. Neoantigens are selected based on criteria that enhance expression and immunogenicity. The vaccine is administered alongside Poly-ICLC, a TLR3 agonist, to enhance immune activation. After the initial vaccine doses, checkpoint inhibitors (e.g., anti-PD-1 or anti-PD-L1) are introduced once neoantigen-specific T-cell responses are detected, preventing immune exhaustion and sustaining a strong immune response. During the follow-up phase, both checkpoint inhibitors and Poly-ICLC are continued to maintain immune activity and ensure a lasting anti-tumor effect.

Inclusion Criteria: Cancer patients will be selected from those receiving treatment at the Cancer Center, Vejthani Hospital. All participants must meet the following criteria: 1. Cancer patients must be aged 18 years or older. 2. Patients must provide informed consent and voluntarily agree to participate in the study. 3. Patients must have an estimated life expectancy of at least 6 months. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and normal functioning of internal organs. 5. Patients must have been diagnosed with cancer based on clinical presentation and confirmed by pathological evidence, including diagnostic imaging. 6. Specific criteria for the cancer type under study: * Advanced-stage cancer: No available standard treatment, resistant to standard therapies, and/or the patient is ineligible or refuses standard treatments. * Early-stage cancer with high recurrence risk: Even after surgery and/or radiation therapy and completion of standard treatment, the cancer has a high risk of recurrence, and there is no clear adjuvant treatment available. 7. Patients must have tumor tissue suitable for analysis and production of neoantigen peptides. 8. For advanced-stage cancer (not in the adjuvant setting), patients must have radiologic evidence that can be used to assess response according to mRECIST1.1 criteria for solid tumors. 9. Patients must have normal liver, kidney, and laboratory function, as indicated by the following criteria: * Lymphocyte count ≥ 800 cells/µL * Neutrophil count ≥ 1,500 cells/µL * Platelet count ≥ 150,000 cells/µL * AST ≤ 2.5 times the upper limit of normal (ULN) * ALT ≤ 2.5 times the ULN * Total bilirubin ≤ 1.5 times the ULN * Serum creatinine ≤ 1.5 times the ULN 10. Patients must agree to avoid pregnancy or causing pregnancy, according to the following: * Female patients not of childbearing potential, defined as those who have had a hysterectomy and/or bilateral oophorectomy, have experienced menopause for more than 12 months, or are aged over 60. * Female patients of childbearing potential must have a negative pregnancy test during the preparation phase and before receiving the first dose of the vaccine. They must also agree to use effective contraception from the preparation phase until 120 days after the last treatment. * Male patients must agree to use effective contraception from the preparation phase until 180 days after the last treatment. Exclusion Criteria: Cancer patients will not be eligible to participate in the study if they meet any of the following conditions: 1. Patients with a known history of allergy to peptide vaccines. 2. Patients with a history of autoimmune disease. 3. Patients who have received chemotherapy or radiation therapy less than 4 weeks prior to enrollment or as determined by the physician. This also includes patients with unresolved side effects from previous treatment graded ≥2 (CTCAE v4.0). 4. Patients with cancer that has metastasized to the brain or central nervous system, unless they have been treated and the metastases are controlled, and have been off steroids for at least 4 weeks. 5. Patients with a history of another malignancy within the past 2 years, except for locally treated basal cell or squamous cell skin cancer. 6. Patients with a history of Human Immunodeficiency Virus (HIV) infection. 7. Patients with a history of Hepatitis B or C infection. For those without prior history, screening will be conducted. Patients who test positive for Hepatitis B (HBsAg) or Hepatitis C (HCV) will be excluded unless: * Hepatitis B is controlled with antiviral treatment, as evidenced by an undetectable viral load. * Hepatitis C has been treated and the viral load is undetectable. 8. Patients with symptomatic or uncontrolled heart disease, including unstable angina, acute myocardial infarction, heart failure (New York Heart Association Class III or IV), or arrhythmias requiring treatment. * Patients with pacemakers may be eligible if their heart rhythm has been stable for at least one month before receiving the neoantigen peptide vaccine. 9. Patients who have received live attenuated or killed vaccines within 28 days prior to the first dose of the neoantigen peptide vaccine. 10. Patients receiving immunosuppressive drugs or corticosteroids at a dose of more than 10 mg of prednisolone (except for inhaled or intranasal corticosteroids) within the last 4 weeks before enrollment. 11. Patients with underlying medical conditions that may interfere with the efficacy or safety of the peptide vaccine. 12. Pregnant or breastfeeding patients.

Locations (1)

Vejthani Hospital

Bangkok, Thailand