Clinical trial NCT06836427: CMTS0929 for Clostridioides Difficile Infection
Official title: CMTS0929 for Clostridioides Difficile Infection: a Prospective, Open-label, Single-arm Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Clostridioides Difficile Infection
Keywords: CMTS0929
Clostridioides difficile infection
efficacy
safety
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible subjects will receive treatment with CMTS0929. They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).

Detailed description: At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics and clinical data will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

1. At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females.
2. At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7).
3. The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

1. Subjects with immunodeficiency (such as HIV infection, or absolute neutrophil count \< 0.5×10⁹/L, or total lymphocyte count \< 0.5×10⁹/L, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g/d prednisone or equivalent steroid hormones).
2. Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET.
3. Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile.
4. Within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery.
5. At the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment.
6. As judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.

Primary outcomes:
measure: The safety of CMTS0929
timeFrame: Four-week
Secondary outcomes:
measure: The safety of CMTS0929
timeFrame: Immediately, One-week, Two-week, Eight-week, Twenty four-week
measure: The complete response rate of CDI-related diarrhea
timeFrame: Four-week, Eight-week
measure: The ultra-early complete response rate of CDI-related diarrhea
timeFrame: One-week post treatment
measure: The early complete response rate of CDI-related diarrhea
timeFrame: Two-week post treatment
measure: The non-response rate of CDI-related diarrhea
timeFrame: Two-week, Four-week, Six-week, Eight-week post treatment
measure: The recurrence rate of CDI-related diarrhea
timeFrame: Four-week, Six-week, Eight-week, Twenty four-week
measure: The major disease progression rate of CDI
timeFrame: Twenty four-week
measure: The salvage/replacement treatment rate of CDI
timeFrame: Immediately, One-week, Two-week, Four-week, Eight-week, Twenty four-week
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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