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Recruiting NCT07556276

Study of CMTS1215 Injection in Patients With Solid Tumors

Phase I / Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CMTS1215 Oncolytic Bacteria.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of CMTS1215 Injection in Subjects With Solid Tumors

Overview

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.

Detailed description

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.

Interventions

  • Biological CMTS1215 Oncolytic Bacteria
    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.

Primary outcome measures

  • Objective Response Rate (ORR) as Assessed by RECIST v1.1 [Time frame: 1 week, 4 weeks,]
  • Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] [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]
Secondary outcome measures (3)
  • Progression-Free Survival (PFS) as Assessed by RECIST v1.1 [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 frame: From first dose through 12 months]
  • CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR [Time frame: Baseline and up to 3 months]

Eligibility criteria

Inclusion criteria

  • 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
  • Expected survival time > 3 months 6 Voluntary participation with signed informed consent

Exclusion criteria

  • 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
  • Lactating female patients
  • Currently participating in other clinical studies
  • Women of childbearing potential planning pregnancy during the study period
  • Patients with allergies to common antibiotics
  • Patients lacking or with restricted legal capacity
  • Other patients deemed unsuitable for enrollment by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affi — Nanjing

Identifiers

NCT: NCT07556276 · CMTS1215-ST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗