Study of CMTS1215 Injection in Patients With Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: CMTS1215 Oncolytic Bacteria

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Faming Zhang, MD, PhD; Phone Number: 086-25-58509883; Email: fzhang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Faming Zhang, MD, PhD; Phone Number: 086-25-58509883; Email: fzhang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CMTS1215 Treatment Group; All enrolled patients will receive CMTS1215 oncolytic bacteria. The dose will be calculated based on tumor size (for intratumoral route) or body weight (for intravenous route). Treatment will be administered via either intratumoral injection (under direct visualization or endoscopic guidance) or intravenous injection for 6-8 cycles. The route of administration will be determined by the investigator based on tumor characteristics and patient condition.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and up to 3 months

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Advanced cancer; Solid tumor; Treatment-refractory cancer
• Other Study ID Numbers: CMTS1215-ST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No