Actively Recruiting
MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors
Led by Ruijin Hospital · Updated on 2025-06-04
10
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, dose-escalation, investigator-initiated exploratory clinical trial designed to evaluate the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of MT027 Cell Injection in patients with advanced primary or secondary peritoneal tumors.
CONDITIONS
Official Title
MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent before any study procedures
- Age between 18 and 70 years, any gender
- Confirmed diagnosis of primary peritoneal tumors with failed first-line therapy
- Confirmed secondary peritoneal tumors with progression after at least two prior standard therapies and no remaining standard options or intolerance to standard therapy
- Presence of at least one evaluable intra-abdominal lesion on contrast-enhanced CT or MRI
- Completed required treatment washout periods before enrollment
- Willingness to provide recent tumor tissue or ascites cells showing B7-H3 positivity or documented B7-H3 positivity in archival tissue
- No intraperitoneal drug injections within 1 month before consent except diagnostic paracentesis
- Life expectancy of at least 3 months
- ECOG performance status score of 0 to 2
- Laboratory values within specified ranges for blood counts, liver, kidney, and coagulation function
- Recovery from prior therapy toxicities to Grade 1 or baseline except alopecia
- Use of highly effective contraception from consent until 180 days after last MT027 dose for males and females of childbearing potential
You will not qualify if you...
- Known allergy to investigational product or its components
- Other cancers within 5 years except certain cured carcinomas
- Contraindications to peritoneal puncture or unsuitable for intraperitoneal therapy
- MSI-H/dMMR colorectal cancer without prior immunotherapy
- Portal vein thrombosis
- Bowel obstruction within 4 weeks before dosing
- Peritoneal adhesions or jelly-like ascites limiting drug diffusion
- Major surgery (except port placement) or abdominal radiotherapy within 4 weeks before first dose
- High-dose systemic corticosteroids use within 4 weeks before treatment
- Participation in other trials within 4 weeks before screening
- Prior therapy targeting the same pathway as MT027
- Severe autoimmune diseases
- Recipients of allogeneic tissue or organ transplants
- Live vaccination within 4 weeks before or planned during the study
- Active infections including certain viral infections
- Active systemic infections, coagulopathy, or serious comorbidities
- Significant organ dysfunction including severe heart, liver, kidney, or lung conditions
- Pregnancy or breastfeeding
- Investigator's judgment of unsuitability based on clinical or lab findings
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jun Zhang
CONTACT
J
Jinlin Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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