Using engineered stem cells to treat advanced solid tumors

Phase I/II Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced/Metastatic Solid Tumors

This study is testing a new type of stem cell treatment to see if it can help people with advanced solid tumors who haven't responded to other therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: prednisone, chemotherapy, immunotherapy, cyclophosphamide
• Locations: 1 site (Beijing)
• Trial ID: NCT05699811 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of interferon alpha expressing mesenchymal stromal cells (MSC-IFNα) in patients with locally advanced or metastatic solid tumors. The study will assess the feasibility of MSC-IFNα treatment, its anti-tumor effects when combined with immunochemotherapy, and the pharmacokinetics and pharmacodynamics of the treatment. The trial is designed as a first-in-human, single-center, prospective, open-label study, focusing on patients who have not responded to standard therapies. By utilizing genetically modified MSCs, the study seeks to enhance the delivery of interferon to the tumor microenvironment, potentially improving treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with confirmed locally advanced or metastatic solid tumors that have not responded to prior treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: While the use of MSCs in cancer therapy is an emerging field, this specific approach of genetically modifying MSCs to express interferon alpha is novel and has not been extensively tested in prior studies.

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 document.
10. 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.

Exclusion Criteria:

1. Active, known, or suspected autoimmune diseases.
2. 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.
3. Subjects are being treated with either corticosteroid (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
4. History of psychiatric disorders including depression, suicidality, and mania.
5. History of allergy or intolerance to study drug components.
6. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
7. 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.
8. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
9. 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.
10. Previous or concurrent cancer within 3 years prior to treatment start.

Where this trial is running

Beijing

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

Study contacts

• Principal investigator: WeiDong Han, PhD — Chinsese PLA Gereral Hospital
• Study coordinator: WeiDong Han, PhD

Conditions: Locally Advanced or Metastatic Solid Tumors