Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

NCT ID: NCT06195384

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2037-12-30

Brief 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. 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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-cancer Neoantigen mRNA Vaccine

Anti-cancer neoantigen mRNA vaccine will be produced to treat advanced solid tumors.

Group Type: EXPERIMENTAL

Neoantigen mRNA Vaccine

Intervention Type: BIOLOGICAL

Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.

Interventions

Neoantigen mRNA Vaccine

Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.

Intervention Type: BIOLOGICAL

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.

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenfeng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenfeng Zhang, MD, PhD

Role: CONTACT

zhangzhf@gzhmu.edu.cn

0086-020-39195965

Bingjia He, MD

Role: CONTACT

464677938@qq.com

+862039195965

Facility Contacts

Zhang Zhenfeng, MD, PhD

Role: primary

zhangzhf@gzhmu.edu.cn

+862039195966

Other Identifiers

ZZVACCINE-mRNA-020

Identifier Type: -

Identifier Source: org_study_id