NCT07556276 Study of CMTS1215 Injection in Patients With Solid Tumors
| NCT ID | NCT07556276 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-03-06 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 18 years or older, any gender 2. Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1 3. 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 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 5. Expected survival time \> 3 months 6 Voluntary participation with signed informed consent Exclusion Criteria: 1. Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia) 2. Active severe clinical infection (\> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection 3. 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) 4. History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation 5. Lactating female patients 6. Currently participating in other clinical studies 7. Women of childbearing potential planning pregnancy during the study period 8. Patients with allergies to common antibiotics 9. Patients lacking or with restricted legal capacity 10. Other patients deemed unsuitable for enrollment by the investigator
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07556276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07556276 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07556276 currently recruiting?
Yes, NCT07556276 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT07556276 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07556276 clinical trial?
NCT07556276 is sponsored by The Second Hospital of Nanjing Medical University. The trial plans to enroll 20 participants.