An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment

Study Overview
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Brief Summary
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Despite years of preclinical efforts and hundreds of clinical studies, therapeutic cancer vaccines with the routine ability to limit or eliminate tumor growth in humans have been elusive. With advances in genome sequencing, it is now possible to identify a new class of tumor-specific antigens derived from mutated proteins that are present only in the tumor. These neoantigens should provide highly specific targets for antitumor immunity. Although many challenges remain in producing and testing neoantigen-based vaccines customized for each patient, a neoantigen vaccine offers a promising new approach to induce highly focused antitumor T cells aimed at eradicating cancer cells

Detailed Description
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Methods of vaccine storage and transportation: as a special biological product, the vaccine should be stored at 2-8 ℃ to protect the efficacy (titer) of the vaccine from being damaged.All vaccines must be stored and transported at temperatures that meet regulatory requirements.A cold chain system is required to support and monitor the temperature at all stages of the vaccine from production to final inoculation (aircraft, ship, train, automobile, motorcycle, bicycle, walking, etc.);Cold storage, refrigerator, vaccine transport box, cold pack, ice bar, etc.) to avoid overheating or over-cooling. Treatment plan: intramuscular injection of vaccines of D1, D4, D7, D14, D21, D51, D142 of the deltoid muscle of the left and right upper arm, every six months for the next 3 years, and every year for the next 3 years, until the patient withdrew from the clinical study or the study was discontinued.

Official Title
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PhaseI Trial of Tumor Neoantigen Vaccine

Conditions
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Cancer

Intervention / Treatment
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* Biological: tumor neoantigen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years ≤ 70 years at the time of informed consent Signed informed consent to be provided failed in previous standard chemotherapy and targeted therapy Life expectancy not less than 90 days Karnofsky performance status 0-1 adequate organ functions Exclusion Criteria: Actively infectious condition including hepatitis Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant. Any form of primary immunodeficiency (such as Severe Combined immunodeficiency Disease). Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). Active systemic infections, coagulation disorders or any other active major medical illnesses. Patients who are receiving any other investigational agents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccinated group<br>Neoantigen vaccination will be performed with 6 doses in total, once per week | Biological: tumor neoantigen<br>* tumor neoantigens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the immunogenic personal neoantigen vaccine | The incidence of serious adverse events | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | It is defined as the proportion of complete response, partial response and stable disease | 1 year |