An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment

Cancer Clinical Trial

Official title:

PhaseI Trial of Tumor Neoantigen Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087252
• Other study ID #: HN2019NIP
• Status: Recruiting
• Phase: Phase 1
• Start date: September 4, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2019
• Source: Henan Cancer Hospital
• Contact: NING LI, Ph.D
• Phone: 13585622468
• Email: lining97[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• tumor neoantigen
tumor neoantigens

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the immunogenic personal neoantigen vaccine	The incidence of serious adverse events	1.5 years
Secondary	Disease control rate	It is defined as the proportion of complete response, partial response and stable disease	1 year