Actively Recruiting
Study of CMTS1215 Injection in Patients With Solid Tumors
Led by The Second Hospital of Nanjing Medical University · Updated on 2026-04-29
20
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of CMTS1215 Injection in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 2
- Expected survival time > 3 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Uncontrolled cardiovascular disease such as heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, or arrhythmia
- Active severe clinical infection above Grade 2 according to 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) or use of anticoagulants or vitamin K antagonists
- 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
- Allergies to common antibiotics
- Patients lacking or with restricted legal capacity
- Other patients deemed unsuitable for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Actively Recruiting
Research Team
F
Faming Zhang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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