IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors
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 question
| Condition(s) | Locally Advanced or Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chinese PLA General Hospital |
| Locations | Beijing, China |
| Start date | 2023-02-23 |
| NCT ID | NCT05699811 |
| Official listing | https://clinicaltrials.gov/study/NCT05699811 |