Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoantigen mRNA Vaccine.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Adult. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
Overview
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
1. Choose appropriate patients with advanced solid cancers, with written consent for this study; 2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis; 3. 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; 4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied; 5. Evaluate the clinical results as needed.
Interventions
- Biological Neoantigen mRNA Vaccine
Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.
Primary outcome measures
- Number of Patients with Dose Limiting Toxicity [Time frame: Six months]
Secondary outcome measures (1)
- Percent of Patients with best response as either complete remission or partial remission. [Time frame: Six months]
Eligibility criteria
Inclusion criteria
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.
\-
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT06195384 · ZZVACCINE-mRNA-020