Study of CMTS1215 Injection in Patients With Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

This is a prospective, open-label, single-arm exploratory clinical trial to evaluate the safety and efficacy of CMTS1215 (Proteus mirabilis) oncolytic bacteria injection for the treatment of solid tumors. The study aims to enroll at least 8 patients with histologically confirmed solid tumors who have failed or are unable to complete conventional first-line, second-line, or third-line anti-tumor therapies.

Key facts

Study ID

NCT07556276

Run by

The Second Hospital of Nanjing Medical University

People needed

20

Starts

2025-03-06

Expected to finish

2030-12-31

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older, any gender
• Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1
• Failed or unable to complete conventional first-line, second-line, or third-line anti-tumor therapies, with multidisciplinary team consensus that no other suitable treatment options are available
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Expected survival time > 3 months 6 Voluntary participation with signed informed consent

You may not qualify if…

• Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia)
• Active severe clinical infection (> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection
• Coagulation abnormalities with bleeding tendency (INR outside normal range without anticoagulants within 14 days prior to enrollment); patients on anticoagulants or vitamin K antagonists (warfarin, heparin, or similar)
• History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation
• Lactating female patients
• Currently participating in other clinical studies
• Women of childbearing potential planning pregnancy during the study period
• Patients with allergies to common antibiotics
• Patients lacking or with restricted legal capacity
• Other patients deemed unsuitable for enrollment by the investigator

Where it is running

• Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.