drugset
drugset / Trial / NCT05699811

IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors

NCT05699811 ↗

Phase 1/2 Recruiting 40 enrolled Chinese PLA General Hospital Wuxi Sinotide New Drug Discovery Institutes · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this first-in-human, single-center, prospective, open-label, phase 1/2 trial is to evaluate the safety and efficacy of the interferon alpha expressing mesenchymal stromal cells (MSC-IFNα) combined with or without immunochemotherapy in patients with locally advanced/metastatic solid tumors. The main questions aimed to answer are 1) to evaluate the safety and feasibility of MSC-IFNα in the treatment of locally advanced/metastatic solid tumors;2) to evaluate the anti-tumor effects of the MSC-IFNα combined with or without immunochemotherapy in the treatment of locally advanced/metastatic solid tumors; 3) to evaluate the pharmacokinetics/pharmacodynamics of MSC-IFNα and related immune effector cells.

Timeline

Start
2023-02-23
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject MSC-IFNα Cell therapy 200000 cells/kg Intravenous
Subject MSC-IFNα Cell therapy 600000 cells/kg Intravenous
Subject MSC-IFNα Cell therapy 2e+06 cells/kg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject Toripalimab Monoclonal antibody 200 mg Intravenous
Background Cyclophosphamide Other / unclassified 200 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous

Indications

No indication recorded.