A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT05869955
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-97540 — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Tocilizumab — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Sep 13, 2023
Status verified
Jun 2026
Primary completion
Aug 29, 2028
Completion
Aug 29, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of CC-97540

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (AEs) in each indication. [ Time Frame: Up to 2 years after CC-97540 infusion ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (31)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Melissa Griffith, Site 0035
720-848-7700
Colorado Blood Cancer InstituteDenverColorado80218
Richard Nash, Site 0024
303-981-2305
Local Institution - 0048New HavenConnecticut06520-
Mayo Clinic in FloridaJacksonvilleFlorida32224
Vikas Majithia, Site 0006
904-953-2000
University of Miami Hospital and Clinics, Sylvester Cancer CenterMiamiFlorida33136
Lazaros Lekakis, Site 0056
305-748-0641
Local Institution - 0053ChicagoIllinois60612-
Local Institution - 0030BaltimoreMaryland21287-
Local Institution - 0038BostonMassachusetts02115
Site 0038
Local Institution - 0046BostonMassachusetts02115-
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
Jonathan Gerber, Site 0032
508-635-7093
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
Roberto Caricchio, Site 0033
267-968-7826
University of MichiganAnn ArborMichigan48109-2800
Monalisa Ghosh, Site 0031
734-936-4000
Henry Ford Medical Center - New Center OneDetroitMichigan48202
Alireza Meysami, Site 0037
313-916-9328
Mayo Clinic in Rochester, MinnesotaRochesterMinnesota55905
Uma Thanarajasingam, Site 0022
507-422-9855
Washington University School of MedicineSt LouisMissouri63110
Alfred Kim, Site 0010
314-326-4785
Local Institution - 0028OmahaNebraska68198-
Atlantic Health System Overlook Medical CenterSummitNew Jersey07901
Neil Kramer, Site 0008
908-598-7940
Columbia University Irving Medical CenterNew YorkNew York10032
Elana Bernstein, Site 0007
212-305-4308
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Margrit Wiesendanger, Site 0011
646-285-7881
Local Institution - 0054New YorkNew York10021-
Local Institution - 0055New YorkNew York10065-
NYU Langone HealthNew YorkNew York10016
Amit Saxena, Site 0002
646-501-7387
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Saira Sheikh, Site 0003
919-966-0545
Cleveland ClinicClevelandOhio44195
Emily Littlejohn, Site 0005
216-445-5559
Local Institution - 0027ColumbusOhio43203-
UT Southwestern Medical CenterDallasTexas75390
Heidi Jacobe, Site 0036
214-648-3348
The University of Texas Health Science Center at HoustonHoustonTexas77030
Maureen Mayes, Site 0029
713-500-6905
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Chitra Hosing, Site 0034
713-745-3219
Fred Hutchinson Cancer CenterSeattleWashington98109
Alexandre Hirayama, Site 0058
206-606-1024
Local Institution - 0057SeattleWashington98105
Site 0057
Swedish Medical CenterSeattleWashington98104
Philip Mease, Site 0004
206-386-2000

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University of Colorado Anschutz Medical Campus· Aurora, COColorado Blood Cancer Institute· Denver, COLocal Institution - 0048· New Haven, CTMayo Clinic in Florida· Jacksonville, FLUniversity of Miami Hospital and Clinics, Sylvester Cancer Center· Miami, FLLocal Institution - 0053· Chicago, IL

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