NCT05916261

Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer

Recruiting now EARLY_PHASE1 Last updated 26 October 2023

What this trial tests

EARLY_PHASE1 trial testing Personalized neoantigen tumor vaccine in Advanced Pancreatic Cancer in 54 participants. Currently enrolling.

Timeline

26 April 2023

Primary endpoint
30 November 2026

30 December 2026

Quick facts

Lead sponsor	Ruijin Hospital
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	26 April 2023
Primary completion	30 November 2026
Estimated completion	30 December 2026
Sites	1 location across China

Drugs / interventions tested

• Personalized neoantigen tumor vaccine — full drug profile →

Conditions studied

• Advanced Pancreatic Cancer — all drugs for Advanced Pancreatic Cancer →

Sponsor

Ruijin Hospital

Who can join

18 and older, any sex, with Advanced Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of Advanced Pancreatic Cancer. The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.

Publications & conference data

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

1. Advances in mRNA-Based Cancer Vaccines.
   Ni L. · · 2023 · cited 33× · PMID 37897001 · DOI 10.3390/vaccines11101599
2. The role of neoantigens and tumor mutational burden in cancer immunotherapy: advances, mechanisms, and perspectives.
   Sun S, Liu L, Zhang J, Sun L, et al · · 2025 · cited 17× · PMID 40898324 · DOI 10.1186/s13045-025-01732-z
3. mRNA cancer vaccines from bench to bedside: a new era in cancer immunotherapy.
   Shariati A, Khani P, Nasri F, Afkhami H, et al · · 2024 · cited 16× · PMID 39696625 · DOI 10.1186/s40364-024-00692-9
4. 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
5. Biomaterials nanoplatform-based tumor vaccines for immunotherapy.
   Li Z, Zhang H, Gong Q, Luo K. · · 2025 · cited 10× · PMID 40678264 · DOI 10.1016/j.bioactmat.2025.06.038
6. Targeting Neoantigens in Pancreatic Ductal Adenocarcinoma.
   Singh G, Kutcher D, Lally R, Rai V. · · 2024 · cited 9× · PMID 38893220 · DOI 10.3390/cancers16112101
7. Artificial Intelligence-Driven Strategies for Targeted Delivery and Enhanced Stability of RNA-Based Lipid Nanoparticle Cancer Vaccines.
   Bhujel R, Enkmann V, Burgstaller H, Maharjan R. · · 2025 · cited 8× · PMID 40871015 · DOI 10.3390/pharmaceutics17080992
8. Advances in Vaccine-Based Therapies for Pancreatic Cancer.
   McMillan MT, Soares KC. · · 2025 · cited 6× · PMID 39939414 · DOI 10.1007/s12029-025-01165-4