NCT07004647

MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors

An Investigator-Initiated, Single-Arm, Dose-Escalation Exploratory Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of MT027 Cell Injection in Patients With Advanced Primary or Secondary Peritoneal Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study evaluates the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intrathecal or intracerebroventricular (ICV) injection of MT027 in glioma treatment. Partial clinical data have been presented at the 2024 ASCO Annual Meeting. Dose Groups: Three predefined dose levels: 1×10⁷ cells/dose、3×10⁷ cells/dose、6×10⁷ cells/dose. Administration frequency: Every 2 weeks (with a 4-week dose-limiting toxicity \[DLT\] observation period after the first injection, followed by subsequent injections every 2 weeks). Dose Escalation: Accelerated titration + 3+3 design: First dose cohort: Accelerated titration strategy. Subsequent cohorts: Standard "3+3" dose-escalation. Dose Adjustment: After reaching predefined dose levels, if no DLT or significant safety events occur, dose escalation decisions (including MTD determination) will be jointly reviewed by investigators and collaborators based on integrated safety and efficacy data. Primary Objectives: To assess the safety, tolerability, and determine the maximum tolerated dose (MTD) of MT027 cell injection in patients with advanced primary or secondary peritoneal tumors.

Conditions

• Peritoneal Tumor

Interventions

Type	Name	Description
DRUG	Fludarabine	D-10 to D-2: Fludarabine (25 mg/m2/day) will be administered intravenously for 3 days;D-10 to D-2: Cyclophosphamide (250 mg/m2/day) will be administered intravenously for 3 days.

Timeline

• Start date: 2025-03-15
• Primary completion: 2028-10-30
• Completion: 2028-11-30
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China