NCT05699811 IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Age from 18 to 75 years with estimated life expectancy \>3 months. 2. Histopathological confirmed locally advanced or metastatic solid tumors including, but not limited to, lung cancer, breast cancer, colorectal cancer, hepatocellular carcinoma, and sarcomas. 3. Failed to at least first-line and second-line treatments or initially diagnosed locally advanced/metastatic solid tumors that have no National Comprehensive Cancer Network(NCCN) guideline-recommended therapy. 4. Have at least one measurable target lesion. 5. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study. 6. Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 2 at the time of enrollment. 7. Have adequate organ function, which should be confirmed within 2 weeks prior to the first dose of study drugs. 8. Previous treatment with anti-PD-1/PD-L1 antibodies is allowed. 9. Ability to understand and sign a written informed consent documen

Related Trials