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IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors
Sponsor: Chinese PLA General Hospital
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.
Official title: Phase I/II Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced/Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-02-23
Completion Date
2026-12-31
Last Updated
2023-04-28
Healthy Volunteers
No
Interventions
MSC-IFNα
MSC-IFNα form a dose of 2×10\^6 cells/kg, intravenous infusion every 4-6 weeks
Nab paclitaxel
125mg/m2, intravenous infusion every 4-6 weeks
Cyclophosphamide
200mg/m2, intravenous infusion every 4-6 weeks
Anti-PD-1 monoclonal antibody
200mg, intravenous infusion every 4-6 weeks
Locations (1)
Department of Biotherapeutic, Chinese PLA General Hospital
Beijing, China