Actively Recruiting
MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
Led by Zhejiang University · Updated on 2025-05-21
12
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response. This investigation comprehensively evaluates the pharmacodynamic and pharmacokinetic profile of MT027 cellular therapy through three primary objectives: (1) systematic monitoring of treatment-emergent adverse events and clinically significant laboratory parameter deviations; (2) assessment of antitumor activity with correlative biomarker analysis; and (3) characterization of cellular kinetics including biodistribution patterns, mechanistic pathways of therapeutic activity, and comprehensive immunogenicity assessment measuring both cellular/humoral immune responses against MT027 cells. The protocol further investigates potential host-versus-product immune reactions through longitudinal monitoring of donor-specific antibodies and cytokine release profiles, while employing advanced molecular tracking methodologies to elucidate cellular persistence and functional modulation within the tumor microenvironment.
CONDITIONS
Official Title
MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily provide signed informed consent before any study procedures
- Age between 18 and 70 years inclusive, any gender
- Diagnosed with advanced primary peritoneal malignancies or abdominal metastatic solid tumors confirmed by pathology or histology
- Have failed at least two prior standard therapies or have no standard treatment options available
- Clear systemic treatment plan with no expected changes during the study
- Confirmed peritoneal metastasis by biopsy, cytology, CT, or prior evidence
- At least one measurable lesion by enhanced CT or evaluable malignant peritoneal effusion by ultrasound
- Willing to provide recent tissue samples or ascites tumor cells for B7-H3 expression testing with confirmed positivity
- No intraperitoneal drug injections within 1 month before consent, except diagnostic paracentesis
- Expected survival of at least 3 months
- ECOG performance status of 0 to 2
- Laboratory values meeting specified blood counts, liver, kidney, and coagulation function criteria
- Recovery of prior treatment toxicities to Grade 1 or baseline (except alopecia)
- Fertile males and females agree to use contraception from consent until 180 days after last MT027 infusion
You will not qualify if you...
- Known allergy to the investigational drug or its components
- Contraindications to peritoneal puncture or unlikely to benefit from intraperitoneal therapy
- MSI-H/dMMR colorectal cancer patients not previously treated with immunotherapy
- Extensive liver metastases exceeding 70% involvement
- Confirmed portal vein thrombosis
- Bowel obstruction within 4 weeks before dosing
- Conditions limiting drug diffusion such as compartmentalized or gelatinous ascites
- Surgery or radiotherapy within 4 weeks before first dose
- Use of systemic steroids or immunosuppressants within 1 week before treatment
- Participation in other drug trials within 4 weeks before screening
- Prior B7-H3-targeted therapy without confirmed B7-H3 positivity
- Severe allergies to components of the investigational drug or biologics
- Concurrent malignancies except cured cervical carcinoma in situ or basal cell carcinoma
- Severe autoimmune diseases
- Prior allogeneic tissue or organ transplant
- Live vaccines within 2 weeks before cell therapy or planned during study
- Active infections including HBV, HCV (unless RNA-negative), HIV, syphilis, EBV, or CMV
- Active systemic infection or coagulation disorders
- Severe heart, liver, kidney, or lung insufficiency
- Pregnancy or breastfeeding
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Weijia Fang
CONTACT
X
Xiaomeng Dai
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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