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NCT05475106
Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms
EARLY_PHASE1 trial testing Neoantigen Peptides in Neoplasms in 100 participants. Currently enrolling.
25 November 2025
Quick facts
| Lead sponsor | Instituto de Medicina Regenerativa |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 12 May 2022 |
| Primary completion | 25 November 2025 |
| Estimated completion | 20 June 2026 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Neoantigen Peptides — full drug profile →
Conditions studied
- Neoplasms — all drugs for Neoplasms →
Sponsor
Instituto de Medicina Regenerativa — full company profile →
Who can join
16 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study is a pilot clinical trial using personalized neoantigen peptide vaccines with the addition of Leukine (Sargramostim), in patients with different types of cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoantigen cancer vaccines: a new star on the horizon.
Li X, You J, Hong L, Liu W, et al · · 2023 · cited 31× · PMID 38164734 · DOI 10.20892/j.issn.2095-3941.2023.0395 -
Cancer Vaccines in the Immunotherapy Era: Promise and Potential.
Verma C, Pawar VA, Srivastava S, Tyagi A, et al · · 2023 · cited 21× · PMID 38140187 · DOI 10.3390/vaccines11121783 -
Overcoming Suppressive Tumor Microenvironment by Vaccines in Solid Tumor.
Xie YJ, Liu WQ, Li D, Hou JC, et al · · 2023 · cited 13× · PMID 36851271 · DOI 10.3390/vaccines11020394 -
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 -
Cancer Nanovaccines: Mechanisms, Design Principles, and Clinical Translation.
Zaccariotto GC, Bistaffa MJ, Zapata AMM, Rodero C, et al · · 2025 · cited 8× · PMID 40202241 · DOI 10.1021/acsnano.4c15765 -
Cancer vaccines: an update on recent achievements and prospects for cancer therapy.
Chekaoui A, Garofalo M, Gad B, Staniszewska M, et al · · 2024 · cited 8× · PMID 39720956 · DOI 10.1007/s10238-024-01541-7 -
The Identification and Clinical Applications of Mutated Antigens in the Era of Immunotherapy.
Kye Y, Nagineni L, Gadad S, Ramirez F, et al · · 2022 · cited 7× · PMID 36077792 · DOI 10.3390/cancers14174255 -
Multi-disciplinary approaches paving the way for clinically effective peptide vaccines for cancer.
Shah BA, Holden JA, Lenzo JC, Hadjigol S, et al · · 2025 · cited 6× · PMID 40204832 · DOI 10.1038/s41541-025-01118-9
Verify or expand the search:
- PubMed search for NCT05475106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Neoantigen Peptides
Trials testing the same drug.
- NCT04509167 — Pilot Study of Neoantigen Peptides for the Treatment of Neoplasms · EARLY_PHASE1 · completed
Other recruiting trials for Neoplasms
Currently open trials in the same condition.
- NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
- NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
- NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
- NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
- NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting
Other Instituto de Medicina Regenerativa trials
Trials by the same sponsor.
- NCT04509167 — Pilot Study of Neoantigen Peptides for the Treatment of Neoplasms · EARLY_PHASE1 · completed
- NCT04456361 — Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19 · EARLY_PHASE1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05475106 (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 Instituto de Medicina Regenerativa
- Last refreshed: 6 March 2024
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/NCT05475106.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing