A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Start Date
9/13/2023
Completion Date
8/29/2028
Summary
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CC-97540
Fludarabine
Cyclophosphamide
Tocilizumab
Conditions
Locations
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
Colorado Blood Cancer Institute
Denver, Colorado 80218
United States
Local Institution - 0048
New Haven, Connecticut 06520
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida 33136
United States
Local Institution - 0053
Chicago, Illinois 60612
United States
Local Institution - 0030
Baltimore, Maryland 21287
United States
Local Institution - 0038
Boston, Massachusetts 02115
United States
Local Institution - 0046
Boston, Massachusetts 02115
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United States
University of Michigan
Ann Arbor, Michigan 48109-2800
United States
Henry Ford Medical Center - New Center One
Detroit, Michigan 48202
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Local Institution - 0028
Omaha, Nebraska 68198
United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey 07901
United States
NYU Langone Health
New York, New York 10016
United States
Local Institution - 0054
New York, New York 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Local Institution - 0055
New York, New York 10065
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Local Institution - 0027
Columbus, Ohio 43203
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Swedish Medical Center
Seattle, Washington 98104
United States
Local Institution - 0057
Seattle, Washington 98105
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
UZ Leuven
Leuven, Vlaams-Brabant 3000
Belgium
Local Institution - 0043
Strasbourg, Alsace 67098
France
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine 33600
France
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault 34295
France
Hopital Claude Huriez - CHU de Lille
Lille, 59037
France
Local Institution - 0040
Nice, 06202
France
Hôpital Saint-Louis
Paris, 75010
France
Local Institution - 0052
Paris, 75679
France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033
France
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria 97080
Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia 50937
Germany
Universitätsklinikum Leipzig
Leipzig, Saxony 04103
Germany
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt 39120
Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Germany
Universitaetsklinikum Erlangen
Erlangen, 91054
Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio 00168
Italy
Humanitas
Rozzano, Milano 20089
Italy
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña] 08036
Spain
Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
H.R.U Málaga - Hospital General
Málaga, 29011
Spain