NCT06141369

Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)

Recruiting now NA Last updated 9 April 2026

What this trial tests

NA trial testing individualized mRNA neoantigen vaccine (mRNA-0523-L001) in Adrenal Cortical Carcinoma in 21 participants. Currently enrolling.

Timeline

13 January 2024

Primary endpoint
30 December 2026

30 June 2027

Quick facts

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	13 January 2024
Primary completion	30 December 2026
Estimated completion	30 June 2027
Sites	1 location across China

Drugs / interventions tested

• individualized mRNA neoantigen vaccine (mRNA-0523-L001) — full drug profile →

Conditions studied

• Adrenal Cortical Carcinoma — all drugs for Adrenal Cortical Carcinoma →
• Medullary Thyroid Cancer — all drugs for Medullary Thyroid Cancer →
• Thymic Neuroendocrine Carcinoma — all drugs for Thymic Neuroendocrine Carcinoma →
• Pancreatic Neuroendocrine Tumor — all drugs for Pancreatic Neuroendocrine Tumor →

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

18 and older, any sex, with Adrenal Cortical Carcinoma or Medullary Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The clinical impact of mRNA therapeutics in the treatment of cancers, infections, genetic disorders, and autoimmune diseases.
   Deyhimfar R, Izady M, Shoghi M, Kazazi MH, et al · · 2024 · cited 17× · PMID 38486748 · DOI 10.1016/j.heliyon.2024.e26971
2. Targeting immunosenescence for improved tumor immunotherapy.
   Liu Z, Zuo L, Zhou Z, Liu S, et al · · 2024 · cited 16× · PMID 39473905 · DOI 10.1002/mco2.777
3. Leveraging mRNA technology for antigen based immuno-oncology therapies.
   Floudas CS, Sarkizova S, Ceccarelli M, Zheng W. · · 2025 · cited 11× · PMID 39848687 · DOI 10.1136/jitc-2024-010569
4. The transformative potential of mRNA vaccines for glioblastoma and human cancer: technological advances and translation to clinical trials.
   Tapescu I, Madsen PJ, Lowenstein PR, Castro MG, et al · · 2024 · cited 9× · PMID 39399167 · DOI 10.3389/fonc.2024.1454370
5. Targeting Neoantigens in Pancreatic Ductal Adenocarcinoma.
   Singh G, Kutcher D, Lally R, Rai V. · · 2024 · cited 9× · PMID 38893220 · DOI 10.3390/cancers16112101
6. mRNA Vaccines: Current Applications and Future Directions.
   Li J, Liu Y, Dai J, Yang L, et al · · 2025 · cited 5× · PMID 41179708 · DOI 10.1002/mco2.70434
7. Unraveling the potential: mRNA therapeutics in oncology.
   Gawalski K, Przybyszewska W, Hunia J, Gawalska A, et al · · 2025 · cited 4× · PMID 40881859 · DOI 10.3389/fonc.2025.1643444
8. Advances and Strategies in Enhancing mRNA Cancer Vaccines.
   Zhang M, Chen S, Hu H, Ong Y, et al · · 2025 · cited 4× · PMID 40772339 · DOI 10.1002/adma.202509880