Study of CMTS1215 Injection in Patients With Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CMTS1215 Oncolytic Bacteria
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov