NCT06314087

Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)

Individualized Tumor Neoantigen Peptide Vaccine in Combination with Unusual Immune Stimulating Radiotherapy in Refractory Solid Tumors (iNATURE) - a Phase II Randomized and Crossover Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: The University of Hong Kong-Shenzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy

Detailed description

In this study, we intend to recruit patients with advanced tumors that have failed standard treatment or progressed, and conduct a clinical study of individualized tumor neoantigen peptide vaccine combined with radiotherapy according to the process shown in the figure below: (1) for operable patients, tumor tissues were obtained surgically with peripheral blood as the control, and for inoperable patients, tumor tissues were obtained by biopsy with peripheral blood as the control, and DNA was extracted and whole exome sequencing was performed to accurately detect the tumor gene mutation. (2) Confirm the expression of the mutation in the tumor by transcriptome sequencing; (3) Analyze the HLA typing of the patient by exon sequencing results; (4) Integrate the information of mutation, gene expression and HLA typing, predict the binding ability of the mutation with HLA molecules by software, and screen the tumour neoantigen. Tumor neoantigens; in this project, for the same data, three teams will be used to perform neoantigen prediction analysis and validate each other, and the neoantigen sequence with the best solution (intersection of the three teams) will be obtained by combining the three results. (5) Synthesize tumor neoantigen peptide vaccine based on tumor neoantigen, and verify the safety of tumor neoantigen peptide vaccine by in vitro in vivo test; (6) Subjects will first receive precision radiotherapy treatment, and then enter into individualized tumor neoantigen peptide vaccine clinical trial after one week to prove the safety, feasibility and effectiveness of this combined precision therapy.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
OTHER	Placebo + conventional treatment including radiotherapy	Placebo + conventional treatment including radiotherapy
COMBINATION_PRODUCT	Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine	The peptide vaccine treatment will take 5 months as a treatment course until the treatment suspension event as stipulated in the plan occurred.

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-08-16
• Completion: 2026-08-31
• First posted: 2024-03-15
• Last updated: 2025-03-25

Locations

2 sites across 1 country: China