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Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 followed by limited duration of anti-PD1 antibody in patients with DLBCL


Clinical Trial Description

The study will consist of 2 phases, a Phase I or dose escalation and expansion phase, and a Phase II. Patients with relapsed or refractory DLBCL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO3 which is a CD19 and CD22 dual targeting CAR T cell product. Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO 3 intravenously as a single dose and in addition a limited duration of treatment with an anti-PD1 antibody (either as part of the pre-conditioning regimen or consolidation). Patients will then enter a 36-month follow-up period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03287817
Study type Interventional
Source Autolus Limited
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 5, 2017
Completion date December 6, 2023

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