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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT07015983
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
16 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

Study Details

The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.

Key Dates

Start date
Jul 14, 2025
Status verified
May 2026
Primary completion
May 17, 2028
Completion
Jun 15, 2032

Study Design

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

Arms

  • Experimental: Administration of CC-97540

Primary Outcome Measure

Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission [ Time Frame: At month 6 ]

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 (40)

FacilityCityStateZIPSite coordinators
Local Institution - 0106ScottsdaleArizona85259
Site 0106
Local Institution - 0038Los AngelesCalifornia90027
Site 0038
Local Institution - 0051Los AngelesCalifornia90095
Site 0051
Local Institution - 0093Newport BeachCalifornia92663
Site 0093
Lucile Packard Children's HospitalPalo AltoCalifornia94304
Jessie Alexander, Site 0035
[email protected]
650-497-7533
University of Colorado Anschutz Medical CampusAuroraColorado80045
Melissa Griffith, Site 0033
720-848-7700
Local Institution - 0105DenverColorado80218
Site 0105
Mayo Clinic in FloridaJacksonvilleFlorida32224
Vikas Majithia, Site 0006
904-953-2000
University of Miami Hospital and Clinics, Sylvester Cancer CenterMiamiFlorida33136
Lazaros Lekakis, Site 0002
305-748-0641
Local Institution - 0073OrlandoFlorida32803
Site 0073
Moffitt Cancer CenterTampaFlorida33612
SAYEEF MIRZA, Site 0036
813-745-5517
USF HealthTampaFlorida33612
Loutfi Succari, Site 0008
813-974-2681
Florida Medical Clinic Orlando HealthZephyrhillsFlorida33542
Julio Gonzalez-Paoli, Site 0062
813-780-8368
Emory University School of MedicineAtlantaGeorgia30322
Arezou Khosroshahi, Site 0078
404-778-6638
Local Institution - 0079AtlantaGeorgia30322
Site 0079
Northside HospitalAtlantaGeorgia30342
Melhem Solh, Site 0076
404-255-1930
Local Institution - 0108IndianapolisIndiana46250
Site 0108
Local Institution - 0086Baton RougeLouisiana70836
Site 0086
Local Institution - 0110ShreveportLouisiana71101
Site 0110
Local Institution - 0094BostonMassachusetts02114
Site 0094
Local Institution - 0096Ann ArborMichigan48109
Site 0096
Local Institution - 0011RochesterMinnesota55905
Site 0011
Atlantic Health System Overlook Medical CenterSummitNew Jersey07901
Neil Kramer, Site 0001
908-598-7940
Local Institution - 0101ManhassetNew York11030
Site 0101
Columbia University Irving Medical CenterNew YorkNew York10032
Laura Geraldino-Pardilla, Site 0005
212-304-6070
Hospital for Special SurgeryNew YorkNew York10021
Kyriakos Kirou, Site 0040
212-606-1728
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Margrit Wiesendanger, Site 0004
646-285-7881
Local Institution - 0082New YorkNew York10016
Site 0082
Local Institution - 0095New YorkNew York10032
Site 0095
Weill Cornell Medical CollegeNew YorkNew York10065
Caitlin Gribbin, Site 0039
Local Institution - 0111Stony BrookNew York11794
Site 0111
Carolinas HealthCare System SouthParkCharlotteNorth Carolina28211
Leslie Ranken, Site 0065
704-355-3162
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Hermine Brunner, Site 0012
513-636-7982
Cleveland ClinicClevelandOhio44195
Emily Littlejohn, Site 0003
216-445-5559
Local Institution - 0083PhiladelphiaPennsylvania19104
Site 0083
Baptist Memorial HospitalMemphisTennessee38120
Sharon Dowell, Site 0092
870-936-7031
Baylor Scott and White Research InstituteDallasTexas75246
Ankit Mehta, Site 0059
214-820-1530
Local Institution - 0098DallasTexas75390-9068
Site 0098
Local Institution - 0104San AntonioTexas78229
Site 0104
Swedish Medical CenterSeattleWashington98122
Philip Mease, Site 0007
206-386-2000

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