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

Recruiting now · Phase 1/Phase 2

Conditions studied: Locally Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT05699811

Run by

Chinese PLA General Hospital

People needed

40

Starts

2023-02-23

Expected to finish

2026-12-31

Last updated by the study team

2023-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study.
• Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 2 at the time of enrollment.
• Have adequate organ function, which should be confirmed within 2 weeks prior to the first dose of study drugs.
• Previous treatment with anti-PD-1/PD-L1 antibodies is allowed.
• Ability to understand and sign a written informed consent document.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and up to 90 days after the last dose of the drug.

You may not qualify if…

• 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.
• History of allergy or intolerance to study drug components.
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Uncontrolled concurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia), or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
• History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before enrollment, and a negative result must be documented.
• Previous or concurrent cancer within 3 years prior to treatment start.

Where it is running

• Department of Biotherapeutic, Chinese PLA General Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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