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Personalized Neoantigen Cancer Vaccine for Patients With Solid Tumors

NCT06614140 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Seqker Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2025-08-15
Completion
2025-08-15

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614140 on ClinicalTrials.gov