NCT07010523

Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors

Exploratory Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cell injection in patients with Mesothelin-positive advanced malignant solid tumors.

Detailed description

In this study, patients with advanced malignant solid tumors with positive MSLN expression will be included. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by Anti-MSLN CAR-T cell injection. The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-MSLN CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-MSLNCAR-T cell injection, and establish recommended phase 2 dose (RP2D).

Conditions

• Mesothelin-positive Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Anti-mesothelin CAR-T cells	D0: 0.1×10\^6/Kg\~1.0×10\^6/Kg; cells will be infused intravenously.
DRUG	Fludarabine	D-7 to D-3: Fludarabine (25 mg/m\^2/day) will be administered intravenously for 5 days.
DRUG	Cyclophosphamide	D-7 to D-3: Cyclophosphamide (300 mg/m\^2/day) will be administered intravenously for 5 days.

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-10-14
• Completion: 2027-10-14
• First posted: 2025-06-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: China