NCT03874897

Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

An Open Label, Single/Multiple Dose Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Cytokinetics of Autologous Humanized Anti-claudin18.2 Chimeric Antigen Receptor T Cell in Advanced Solid Tumor Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.

Detailed description

This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CAR-CLDN18.2 T-Cells	Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses • Chimeric Antigen Receptor T Cells Targeting Claudin18.2
DRUG	PD-1 Monoclonal Antibody	Chimeric Antigen Receptor T Cells Targeting Claudin18.2 with PD-1
DRUG	Chemotherapy	First-line systemic therapy according to physician's choice

Timeline

• Start date: 2019-03-26
• Primary completion: 2021-03-20
• Completion: 2024-01-26
• First posted: 2019-03-14
• Last updated: 2024-04-30

Locations

3 sites across 1 country: China