NCT05783089

MSLN-targeted CAR-T Cells in Solid Tumors.

Anti-Mesothelin CAR-T Therapy in Subjects With Mesothelin-positive Advanced Malignant Solid Tumors.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cells in subjects with Mesothelin-positive advanced malignant solid tumors.

Detailed description

This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cells. Patients will be confirmed to have sufficient expression of mesothelin as part of a prescreening. The study comprises a dose-escalation component and a dose-expansion component. There are three cohorts in dose-expansion component. Cohort 1: To explore the effects of different conditioning chemotherapy regimens on safety, tolerability and efficacy; Cohort 2: To explore the effects of different administration modes (intravenous injection and local injection) on safety, tolerability and efficacy; Cohort 3: To explore the effects of combination immune checkpoint inhibitors on safety, tolerability and efficacy.

Conditions

• Mesothelin-positive Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Anti-mesothelin CAR-T cells	Anti-mesothelin CAR-T cells are autologous genetically modified T cells. Cells will be infused intravenously.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-04-01
• Completion: 2027-04-01
• First posted: 2023-03-24
• Last updated: 2023-03-24