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An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04087252
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
shanghai neoimmune pharmaceutical technology compony
Information provided by (Responsible Party):
Henan Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Cancer Biological: tumor neoantigen Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PhaseI Trial of Tumor Neoantigen Vaccine
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 30, 2021

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

Primary Outcome Measures :
  1. Safety of neoantigen peptide vaccine as measured by the number of serious adverse events [ Time Frame: 3 months ]
    -Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 3months ]
    The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Percentage of Participants Achieving a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate) Participants achieved disease control if they had a best overall response of CR, PR or SD.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04087252

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Contact: NING LI, Ph.D 13585622468

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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Ning Li, PhD         
Principal Investigator: Suxia Luo, PhD         
Sponsors and Collaborators
Henan Cancer Hospital
shanghai neoimmune pharmaceutical technology compony

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Responsible Party: Henan Cancer Hospital Identifier: NCT04087252     History of Changes
Other Study ID Numbers: HN2019NIP
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs