CancerPhase 1NCT04087252
An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment
A Phase 1 study testing tumor neoantigen in people with Cancer, run by Henan Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- tumor neoantigen
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2019to 30 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Ning Li, PhD
Suxia Luo, PhD
About this study
Official title: 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
Read the detailed description
- 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.
- 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.
- Conditions
- Cancer
- Being tested
- tumor neoantigen
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor neoantigenBiological
tumor neoantigens
| Study group | Role | What they receive |
|---|---|---|
| vaccinated group | Experimental | Neoantigen vaccination will be performed with 6 doses in total, once per week Receives: Biological: tumor neoantigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the immunogenic personal neoantigen vaccine
The incidence of serious adverse events
Measured: 1.5 years
Secondary outcomes (1)
Disease control rate
It is defined as the proportion of complete response, partial response and stable disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start4 Sep 2019
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ning Li, PhD, Principal investigator, Henan Cancer HospitalSuxia Luo, PhD, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087252
- Sponsor's protocol ID
- HN2019NIP
- Status last verified
- Aug 2019
- First submitted
- 3 Sep 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseI Trial of Tumor Neoantigen Vaccine
- ClinicalTrials.gov ID
- NCT04087252
- Acronym / sponsor ID
- HN2019NIP
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccinated group | Experimental | Biological: tumor neoantigenNeoantigen vaccination will be performed with 6 doses in total, once per week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tumor neoantigentumor neoantigens | Biological | vaccinated group |
Primary outcome
Safety of the immunogenic personal neoantigen vaccine
Time frame: 1.5 years
The incidence of serious adverse events
1 secondary outcome
Disease control rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, PhD principal investigator
Henan Cancer Hospital
Suxia Luo, PhD principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tumor neoantigen in people with Cancer, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NING LI, Ph.D (13585622468, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the immunogenic personal neoantigen vaccine (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.