Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Biological: Neoantigen mRNA Vaccine

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhenfeng Zhang, MD, PhD; Phone Number: 0086-020-39195965; Email: zhangzhf@gzhmu.edu.cn
• Study Contact Backup: Name: Bingjia He, MD; Phone Number: +862039195965; Email: 464677938@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-cancer Neoantigen mRNA Vaccine; Anti-cancer neoantigen mRNA vaccine will be produced to treat advanced solid tumors.	Biological: Neoantigen mRNA Vaccine; Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Zhenfeng Zhang, MD, PhD, Second Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2037

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Immunotherapy; Solid Tumor; mRNA Vaccine
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ZZVACCINE-mRNA-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No