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.
Oncolytic bacteria are a class of bacteria that can specifically reproduce within tumors and cause tumor cell death while activating the host immune system. CMTS1215 is a Proteus mirabilis strain developed by the research team with demonstrated oncolytic effects in preclinical studies. The bacteria show excellent tumor tropism and have been shown to be safe and effective in mouse and canine models. This study will evaluate the tumor response rate at 1 week and 4 weeks post-treatment according to RECIST 1.1 criteria, as well as assess the safety profile of the treatment. Patients will receive intratumoral injection of CMTS1215 under direct visualization or endoscopic guidance for up to 6-8 treatment cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CMTS1215 is a bacterial therapeutic preparation designated with the code CMTS1215. The mechanism of action may involve bacterial membrane proteins that facilitate tumor-targeting properties. CMTS1215 is administered via intratumoral injection (under direct visualization or endoscopic guidance) or intravenous injection, with dosage calculated based on tumor size.
Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGObjective Response Rate (ORR) as Assessed by RECIST v1.1
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Time frame: 1 week, 4 weeks,
Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to dose modification or discontinuation, graded by CTCAE v5.0.
Time frame: From informed consent through 6 months after the last dose of CMTS1215, or until resolution of any ongoing treatment-related adverse events, whichever is longer
Progression-Free Survival (PFS) as Assessed by RECIST v1.1
Time from first dose of CMTS1215 to radiographic disease progression or death from any cause, whichever occurs first, based on investigator assessment per RECIST v1.1 criteria.
Time frame: From first dose through 12 months, or until disease progression/death
Overall Survival (OS) Defined as Time from First Dose to Death from Any Cause
Time from first dose of CMTS1215 to death from any cause. Participants alive at last contact will be censored at that date.
Time frame: From first dose through 12 months
CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR
Absolute quantification of CMTS1215-specific genomic DNA in tumor biopsy samples by qPCR, expressed as log₁₀ copies per microgram of tissue DNA.
Time frame: Baseline and up to 3 months
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