drugset / Trial / NCT05631899

CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors

NCT05631899 ↗

Phase 1 Active not recruiting 9 enrolled Chinese PLA General Hospital Zhejiang University · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with KRAS mutant peptide (KRAS-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of KRAS-EphA-2-CAR-DC vaccine; detect T cell response against KRAS mutant peptide and tumor neoepitopes after the treatment with KRAS-EphA-2-CAR-DC vaccine and ICIs.

Timeline

Start
2023-04-03
Primary completion
2026-06-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject KRAS-EphA-2-CAR-DC Cell therapy — Intravenous
Background Abraxane Small molecule 125 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous

Indications