A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

PHASE2RecruitingINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

July 14, 2025

Primary Completion Date

May 17, 2028

Study Completion Date

June 15, 2032

Conditions
Lupus Erythematosus, SystemicLupus Nephritis
Interventions
DRUG

CC-97540

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

Trial Locations (76)

1090

NOT_YET_RECRUITING

Local Institution - 0037, Vienna

2100

NOT_YET_RECRUITING

Local Institution - 0047, Copenhagen

3000

NOT_YET_RECRUITING

Local Institution - 0020, Leuven

5000

NOT_YET_RECRUITING

Local Institution - 0056, Odense

5020

NOT_YET_RECRUITING

Local Institution - 0031, Salzburg

10021

NOT_YET_RECRUITING

Local Institution - 0040, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10032

NOT_YET_RECRUITING

Local Institution - 0005, New York

10065

NOT_YET_RECRUITING

Local Institution - 0039, New York

10117

NOT_YET_RECRUITING

Local Institution - 0026, Berlin

20162

NOT_YET_RECRUITING

Local Institution - 0032, Milan

27599

WITHDRAWN

Local Institution - 0010, Chapel Hill

28211

NOT_YET_RECRUITING

Local Institution - 0065, Charlotte

29011

NOT_YET_RECRUITING

Local Institution - 0014, Málaga

30322

NOT_YET_RECRUITING

Local Institution - 0078, Atlanta

NOT_YET_RECRUITING

Local Institution - 0079, Atlanta

32224

RECRUITING

Mayo Clinic in Florida, Jacksonville

32804

WITHDRAWN

Local Institution - 0073, Orlando

33136

NOT_YET_RECRUITING

Local Institution - 0002, Miami

33542

NOT_YET_RECRUITING

Local Institution - 0062, Zephyrhills

33612

NOT_YET_RECRUITING

Local Institution - 0008, Tampa

NOT_YET_RECRUITING

Local Institution - 0036, Tampa

34295

NOT_YET_RECRUITING

Local Institution - 0018, Montpellier

35033

NOT_YET_RECRUITING

Local Institution - 0019, Rennes

39120

NOT_YET_RECRUITING

Local Institution - 0030, Magdeburg

44195

RECRUITING

Cleveland Clinic, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

50937

NOT_YET_RECRUITING

Local Institution - 0029, Cologne

55905

WITHDRAWN

Local Institution - 0011, Rochester

56126

NOT_YET_RECRUITING

Local Institution - 0070, Pisa

73104

NOT_YET_RECRUITING

Local Institution - 0041, Oklahoma City

75013

NOT_YET_RECRUITING

Local Institution - 0064, Paris

75246

RECRUITING

Baylor Scott and White Research Institute, Dallas

80045

RECRUITING

University of Colorado Anschutz Medical Campus, Aurora

90027

NOT_YET_RECRUITING

Local Institution - 0038, Los Angeles

90095

NOT_YET_RECRUITING

Local Institution - 0051, Los Angeles

91054

NOT_YET_RECRUITING

Local Institution - 0027, Erlangen

94304

RECRUITING

Lucile Packard Children's Hospital, Palo Alto

96813

WITHDRAWN

Local Institution - 0074, Honolulu

98122

NOT_YET_RECRUITING

Local Institution - 0007, Seattle

1608582

NOT_YET_RECRUITING

Local Institution - 0069, Shinjuku-ku

5262100

NOT_YET_RECRUITING

Local Institution - 0043, Ramat Gan

9112001

NOT_YET_RECRUITING

Local Institution - 0042, Jerusalem

35294-3300

NOT_YET_RECRUITING

Local Institution - 0009, Birmingham

02215

NOT_YET_RECRUITING

Local Institution - 0052, Boston

07901

RECRUITING

Atlantic Health System Overlook Medical Center, Summit

C1199ABB

NOT_YET_RECRUITING

Local Institution - 0016, ABB

WITHDRAWN

Local Institution - 0017, ABB

C1118AAT

NOT_YET_RECRUITING

Local Institution - 0023, Buenos Aires

X5016

NOT_YET_RECRUITING

Local Institution - 0077, Córdoba

01509-010

NOT_YET_RECRUITING

Local Institution - 0058, São Paulo

01409-902

NOT_YET_RECRUITING

Local Institution - 0021, São Paulo

05652-900

NOT_YET_RECRUITING

Local Institution - 0022, São Paulo

V5Z 1M9

NOT_YET_RECRUITING

Local Institution - 0048, Vancouver

M5G 1X8

NOT_YET_RECRUITING

Local Institution - 0045, Toronto

04103

NOT_YET_RECRUITING

Local Institution - 0028, Leipzig

00168

NOT_YET_RECRUITING

Local Institution - 0025, Rome

00165

NOT_YET_RECRUITING

Local Institution - 0044, Rome

0608648

NOT_YET_RECRUITING

Local Institution - 0055, Sapporo

236-0004

NOT_YET_RECRUITING

Local Institution - 0072, Yokohama

113-8431

NOT_YET_RECRUITING

Local Institution - 0068, Bunkyo-ku

260-8677

NOT_YET_RECRUITING

Local Institution - 0067, Chiba

812-8582

NOT_YET_RECRUITING

Local Institution - 0054, Fukuoka

700-8558

NOT_YET_RECRUITING

Local Institution - 0063, Okayama

545-8586

NOT_YET_RECRUITING

Local Institution - 0053, Osaka

1105 AZ

WITHDRAWN

Local Institution - 0046, Amsterdam

41-902

NOT_YET_RECRUITING

Local Institution - 0024, Bytom

44-101

NOT_YET_RECRUITING

Local Institution - 0049, Gliwice

93-513

WITHDRAWN

Local Institution - 0034, Lodz

1649-035

NOT_YET_RECRUITING

Local Institution - 0013, Lisbon

08035

NOT_YET_RECRUITING

Local Institution - 0015, Barcelona

08950

NOT_YET_RECRUITING

Local Institution - 0071, Esplugues de Llobregat

NW1 2PG

NOT_YET_RECRUITING

Local Institution - 0060, London

WITHDRAWN

Local Institution - 0061, London

SE5 9RL

NOT_YET_RECRUITING

Local Institution - 0050, London

W1T 7HA

NOT_YET_RECRUITING

Local Institution - 0057, London

All Listed Sponsors
lead

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

INDUSTRY

NCT07015983 - A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) | Biotech Hunter | Biotech Hunter