An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment

PhaseI Trial of Tumor Neoantigen Vaccine

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

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Biological: tumor neoantigen

Detailed Description

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
      • Principal Investigator: Suxia Luo, PhD
      • Contact: Ning Li, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: Suxia Luo, PhD, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HN2019NIP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No