NCT07504484

Safety and Efficacy of Neoantigen-Based Personalized Immunotherapy as Consolidation Therapy After Standard Adjuvant Treatment in Resectable Stage III Colorectal Cancer or Non-Small Cell Lung Cancer

A Clinical Study on the Safety and Efficacy of Personalized Immunotherapy Based on Neoantigens as Consolidation Therapy Following Standard Postoperative Adjuvant Treatment in Patients With Stage III Resectable Colorectal Cancer or Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ying Yuan, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety, efficacy, and methodological feasibility of sequential administration of neoantigen-based personalized immunotherapy following completion of standard adjuvant therapy in patients with colorectal cancer or non-small cell lung cancer who have undergone radical resection. Based on previous safety clinical trial results of personalized anti-tumor neoantigen injections, the 300 μg/peptide dose is well tolerated. Therefore, this study will assess the safety and preliminary efficacy of personalized anti-tumor neoantigen injections at a dose of 300 μg/peptide as consolidation therapy after standard postoperative adjuvant treatment in patients with stage III resectable colorectal cancer or non-small cell lung cancer, aiming to provide novel personalized therapeutic strategies to improve disease-free survival (DFS) and overall survival (OS) in these patients.

Conditions

• CRC (Colorectal Cancer)
• Non Small Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	iNeo-Vac-P01	iNeo-Vac-P01 employs neoantigen peptides to activate the body's immune system, thereby eliminating residual tumor cells after surgery and preventing tumor recurrence and metastasis, enabling patients to derive greater benefit from personalized immunotherapy. For iNeo-Vac-P01, an innovative personalized immunotherapy based on neoantigens, the administration regimen is as follows: Personalized anti-tumor neoantigen injection (300 μg/peptide) plus GM-CSF (40 μg per injection site) will be administered via subcutaneous injection at multiple sites (around the upper arms and abdomen). Five priming immunizations will be given on Days 1, 4, 8, 15 ± 3, and 22 ± 3. Booster immunizations will be administered on Days 52 ± 7 and 82 ± 7. Additional booster doses may be given at 2-month intervals based on the subject's clinical benefit.

Timeline

• Start date: 2020-10-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China