An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment

NCT04087252 | Unknown Phase 1 DMC

• 1 other identifier: HN2019NIP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Safety of the immunogenic personal neoantigen vaccine

  The incidence of serious adverse events

  1.5 years

Secondary Outcomes (1)

• Disease control rate

  1 year

Study Arms (1)

vaccinated group

EXPERIMENTAL

Neoantigen vaccination will be performed with 6 doses in total, once per week

Biological: tumor neoantigen

Interventions

tumor neoantigen BIOLOGICAL

tumor neoantigens

vaccinated group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ning Li, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Suxia Luo, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NING LI, Ph.D

CONTACT

13585622468; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 12, 2019
• Study Start: September 4, 2019
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 15, 2020

Record last verified: 2019-08

Locations

CN (1)