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Clinical Trial Summary

This is a single institution Phase I study to determine the maximum tolerated dose (MTD) of E7777 when given prior to cyclophosphamide/fludarabine (CY/Flu) lymphodepletion (LD) chemotherapy and Kymriah, a commercial tisagenlecleucel product, for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are at a higher risk for failure of CAR-T therapy.

Clinical Trial Description

E7777 is a recombinant fusion toxin consisting of full-length human IL-2 fused to the catalytic domains of diphtheria toxin. This trial is designed to augment lymphodepletion prior to CAR-T cells by administration of a targeted immunotoxin against CD25-expressing T-cells. CD25 is expressed at high levels on Tregs but also on activated effector T cells. The use of the CAR-T cell product and associated apheresis and LD chemotherapy is considered standard of care (SOC). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04855253
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact Cancer Center Clinical Trials Office
Phone 612-676-4200
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date May 1, 2021
Completion date December 2024

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