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RECRUITING
NCT05699811
PHASE1/PHASE2

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

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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

BIOLOGICAL

MSC-IFNα

MSC-IFNα form a dose of 2×10\^6 cells/kg, intravenous infusion every 4-6 weeks

DRUG

Nab paclitaxel

125mg/m2, intravenous infusion every 4-6 weeks

DRUG

Cyclophosphamide

200mg/m2, intravenous infusion every 4-6 weeks

DRUG

Anti-PD-1 monoclonal antibody

200mg, intravenous infusion every 4-6 weeks

Locations (1)

Department of Biotherapeutic, Chinese PLA General Hospital

Beijing, China