A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies

Study Summary

CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.

Interventions

Study Locations

Facility	City	State	Country
City of Hope National Medical Center	Duarte	California	United States
University of California at San Diego	San Diego	California	United States
University of Chicago	Chicago	Illinois	United States
Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States
Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York	United States
Wake Forest Baptist Health	Winston-Salem	North Carolina	United States
Sarah Cannon Research Institute - Tennessee Oncology	Nashville	Tennessee	United States
Sarah Cannon Research Institute - Texas Transplant Institute	San Antonio	Texas	United States

Official Trial Information

View on ClinicalTrials.gov