Trials / Recruiting
RecruitingNCT06141369
Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Shanghai Jiao Tong University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Treatment of advanced endocrine tumors, including adrenal corticocarcnioma (ACC), medullary thyroid carcinoma (MTC), thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging. Previous genomic profiling studies showed they presented a number of somatic mutations. The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen. The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine (mRNA-0523-L001) for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available. The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available, including: 1. Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001; 2. Objective response rate (ORR) and disease control rate (DCR) of tumors; 3. Progression-free survival (PFS).
Conditions
- Adrenal Cortical Carcinoma
- Medullary Thyroid Cancer
- Thymic Neuroendocrine Carcinoma
- Pancreatic Neuroendocrine Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | individualized mRNA neoantigen vaccine (mRNA-0523-L001) | Individualized mRNA neoantigen vaccine (mRNA-0523-L001) will be injected intramuscularly every 21 days for 9 cycles. Dose escalation will be administered in 3 patients. 18 additional patients will be recruited and administered at the maximum tolerated(MTD) dose for all nine cycles. Injection of mRNA-0523-L001 will continue if an objective response is observed until the discontinuation criteria are met. |
Timeline
- Start date
- 2024-01-13
- Primary completion
- 2026-12-30
- Completion
- 2027-06-30
- First posted
- 2023-11-21
- Last updated
- 2026-04-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06141369. Inclusion in this directory is not an endorsement.