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MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
Sponsor: Zhejiang University
Summary
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.
Official title: Phase I Dose-Escalation Study of MT027: Evaluating Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-05-12
Completion Date
2028-12-31
Last Updated
2025-05-21
Healthy Volunteers
No
Interventions
MT027 CAR-T cells
Prior to MT027 cell infusion, lymphodepleting chemotherapy with fludarabine and cyclophosphamide was administered. Dose Group 1: 1×10⁷ cells per administration; Dose Group 1: 3×10⁷ cells per administration; Dose Group 1: 6×10⁷ cells per administration; Based on the data obtained, adjustments to the specific number of cells in the established dosage groups and/or the addition of dosage groups may be made after discussion between the collaborators and researchers. A dose reduction titration may also be conducted based on the completed dosage groups.
Locations (1)
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China