Solid Tumor, AdultPhase 1NCT06195384
Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors
A Phase 1 study testing Neoantigen mRNA Vaccine in people with Solid Tumor, Adult, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Neoantigen mRNA Vaccine
- 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
- 8 May 2024to 30 Dec 2037
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with advanced cancer; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- -
Who cannot join
- Had accepted gene therapy before;
- Severe virus infection such as HBV, HCV, HIV, et al;
- Known HIV positivity;
- Active infectious disease related to bacteria, virus,fungi,et al;
- Other severe diseases that the investigators consider not appropriate;
- Pregnant or lactating women;
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
- Other conditions that the investigators consider not appropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Zhang Zhenfeng, MD, PhD, +862039195966, zhangzhf@gzhmu.edu.cn
About this study
Official title: Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.
Read the detailed description
- Choose appropriate patients with advanced solid cancers, with written consent for this study;
- Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
- Produce high quality mRNA vaccine and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
- To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
- Evaluate the clinical results as needed.
- Conditions
- Solid Tumor, Adult
- Being tested
- Neoantigen mRNA Vaccine
- Keywords
- mRNA Vaccine, Solid Tumor, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen mRNA VaccineBiological
Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.
| Study group | Role | What they receive |
|---|---|---|
| Anti-cancer Neoantigen mRNA Vaccine | Experimental | Anti-cancer neoantigen mRNA vaccine will be produced to treat advanced solid tumors. Receives: Biological: Neoantigen mRNA Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Dose Limiting Toxicity
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
Measured: Six months
Secondary outcomes (1)
Percent of Patients with best response as either complete remission or partial remission.
Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start8 May 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195384
- Sponsor's protocol ID
- ZZVACCINE-mRNA-020
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT06195384
- Acronym / sponsor ID
- ZZVACCINE-mRNA-020
- Conditions
- Solid Tumor, Adult
- Keywords
- mRNA Vaccine, Solid Tumor, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2037 (estimated)
- First posted
- 8 Jan 2024 (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.
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.
Detailed description
- Choose appropriate patients with advanced solid cancers, with written consent for this study;
- Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
- Produce high quality mRNA vaccine and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
- To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
- Evaluate the clinical results as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-cancer Neoantigen mRNA Vaccine | Experimental | Biological: Neoantigen mRNA VaccineAnti-cancer neoantigen mRNA vaccine will be produced to treat advanced solid tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients with advanced cancer; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- -
Key exclusion criteria (8 listed)
- Had accepted gene therapy before;
- Severe virus infection such as HBV, HCV, HIV, et al;
- Known HIV positivity;
- Active infectious disease related to bacteria, virus,fungi,et al;
- Other severe diseases that the investigators consider not appropriate;
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 |
|---|---|---|
| Neoantigen mRNA VaccineDeliver neoantigen mRNA vaccine into patients for anti-ancer therapy. | Biological | Anti-cancer Neoantigen mRNA Vaccine |
Primary outcome
Number of Patients with Dose Limiting Toxicity
Time frame: Six months
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
1 secondary outcome
Percent of Patients with best response as either complete remission or partial remission.
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Zhenfeng Zhang, MD, PhD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
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 Neoantigen mRNA Vaccine in people with Solid Tumor, Adult, run by Second Affiliated Hospital of Guangzhou Medical University 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenfeng Zhang, MD, PhD (0086-020-39195965, zhangzhf@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Dose Limiting Toxicity (time frame: Six months). 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 26 Jun 2024.