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Anti-mesothelin CAR-T Cells With Advanced Refractory Solid Tumors — Amaretto  

Refractory Malignant Solid Neoplasm Clinical Trial

Official title:
An Open, Single-center, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of mRNA CAR-mesothelin T Cells in Patients With Advanced Refractory Solid Tumors

Clinical Trial Summary

The goal of this clinical trial is to study the safety, efficacy, and pharmacokinetics of mRNA-engineered anti-Mesothelin (MESO) Chimeric Antigen Receptor T-Cell (CAR-T cells) therapy in patients with mesothelin expression-positive, advanced solid tumors that have failed at least first-line or second-line therapy.

Clinical Trial Description

This phase I study is being conducted to establish safety, pharmacokinetics, and preliminary efficacy of intravenous (IV) mRNA electroporated fully-humanized anti-MESO re-directed autologous T cell administration in patients with chemotherapy-refractory metastatic solid tumors. The study will adopt the "3+3" dose escalation design exploring two doses of 1×109 and 3×109. The administration is planned to infuse 3 times a week for 2 consecutive weeks. • The subjects will receive a total dose of 1x109 RNA transduced anti-MESO CAR-T cells in the first week, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given over 3 days by intravenous infusion. If there is no obvious dose-limiting toxicity (DLT) after the first week of infusion, three times consecutive infusions of 1x109 anti-MESO CAR-T cells each time is planned in the second week. Each subject needs to be observed for at least 2 weeks (14 days) after completing the last infusion. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of anti-MESO CAR-T cells. ;

Study Design

Related Conditions & MeSH terms

  • Refractory Malignant Solid Neoplasm
Clinical Trial Details
NCT number NCT04981691
Study type Interventional
Source Ruijin Hospital
Contact Jun Zhang, MD, PhD
Phone 0086-13818332497
Email junzhang10977@sjtu.edu.cn
Status Recruiting
Phase Phase 1
Start date October 1, 2021
Completion date July 9, 2022
View Details
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