IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital
About this trial
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
Qualifiers
Age from 18 to 75 years with estimated life expectancy >3 months.
Histopathological confirmed locally advanced or metastatic solid tumors including, but not limited to, lung cancer, breast cancer, colorectal cancer, hepatocellular carcinoma, and sarcomas.
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.
Have at least one measurable target lesion.
Disqualifiers
Active, known, or suspected autoimmune diseases.
Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms, and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
Subjects are being treated with either corticosteroid (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
History of psychiatric disorders including depression, suicidality, and mania.
Trial design
Treatments tested in this trial
- MSC-IFNα
- Nab paclitaxel
- Cyclophosphamide
- Anti-PD-1 monoclonal antibody
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
Wuxi Sinotide New Drug Discovery Institutes
Collaborator
Source ClinicalTrials.gov