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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CMTS1215 Oncolytic Bacteria
Biological/VaccineCMTS1215 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CMTS1215 Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective 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,2
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 longerSecondary outcomes
1
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/death2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov