Clinical trial NCT04087252: An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment
Official title: PhaseI Trial of Tumor Neoantigen Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the immunogenic personal neoantigen vaccine
timeFrame: 1.5 years
Secondary outcomes:
measure: Disease control rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Ning Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Cancer Hospital
name: Suxia Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References: