NCT05916248 is a EARLY_PHASE1 clinical trial of Personalized neoantigen tumor vaccine in Advanced Solid Tumor, sponsored by Ruijin Hospital.

Who is sponsoring NCT05916248?

NCT05916248 is sponsored by Ruijin Hospital.

What drugs are being tested in NCT05916248?

Interventions in NCT05916248: Personalized neoantigen tumor vaccine, PD-1 inhibitor.

What condition does NCT05916248 study?

NCT05916248 studies Advanced Solid Tumor.

Is NCT05916248 still recruiting?

NCT05916248 is currently recruiting now. Last updated 1 April 2025.

Last reviewed 2025-04-01 · How we verify

NCT05916248

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors

Recruiting now EARLY_PHASE1 Last updated 1 April 2025

What this trial tests

EARLY_PHASE1 trial testing Personalized neoantigen tumor vaccine in Advanced Solid Tumor in 34 participants. Currently enrolling.

Timeline

20 December 2023

Primary endpoint
30 June 2026

30 December 2026

Quick facts

Lead sponsor	Ruijin Hospital
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	20 December 2023
Primary completion	30 June 2026
Estimated completion	30 December 2026
Sites	1 location across China

Drugs / interventions tested

Personalized neoantigen tumor vaccine — full drug profile →
PD-1 inhibitor — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Ruijin Hospital

Who can join

18 and older, any sex, with Advanced Solid Tumor. 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 solid tumors. 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):

Advances in mRNA-Based Cancer Vaccines.
Ni L. · · 2023 · cited 33× · PMID 37897001 · DOI 10.3390/vaccines11101599
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
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
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
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
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
mRNA vaccines and SiRNAs targeting cancer immunotherapy: challenges and opportunities.
Lv Z, Dai Y. · · 2025 · cited 6× · PMID 40615758 · DOI 10.1007/s12672-025-03070-5
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

Verify or expand the search:

Other trials of Personalized neoantigen tumor vaccine

Trials testing the same drug.

NCT07334574 — Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL · Phase 1 · not yet recruiting
NCT06980155 — XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Ac · EARLY_PHASE1 · recruiting
NCT05916261 — Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer · EARLY_PHASE1 · recruiting

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting

Other Ruijin Hospital trials

Trials by the same sponsor.

NCT07589361 — Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors · not yet recruiting
NCT07449507 — Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy · NA · not yet recruiting
NCT07496385 — Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound · NA · not yet recruiting
NCT07511114 — A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyp · Phase 3 · not yet recruiting
NCT07514169 — The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05916248 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ruijin Hospital
Last refreshed: 1 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05916248.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing