Clinical trial NCT07015983: A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
Official title: A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Lupus Nephritis
Keywords: Lupus
SLE
LN
CAR T
Cell Therapy
CD19 CAR T
CD19
CD19 NEX-T
CD19 NEXT
CD19 NEX T
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 89
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria

* Participants must meet EULAR/ACR 2019 criteria for SLE.
* Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.
* Participants must have active disease when signing ICF.

Key Exclusion Criteria:

* Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
* Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.
* IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study.
* Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant. Washout periods may be required.
* Participants must not have received live vaccines within 6 weeks before CC-97540 administration.
* Participant must not have inadequate organ function.
* Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
timeFrame: At month 6
Secondary outcomes:
measure: Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
timeFrame: Up to Month 60
measure: Participants with drug-free DORIS remission
timeFrame: Up to month 60
measure: CRR for participants with baseline LN
timeFrame: Up to month 60
measure: Modified CRR for participants with baseline LN
timeFrame: Up to month 60
measure: Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6
timeFrame: Up to month 60
measure: Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6
timeFrame: Up to month 60
measure: Number of participants with flares as assessed by SLEDAI flare index
timeFrame: Up to month 60
measure: Severity of participants with flares as assessed by SLEDAI flare index
timeFrame: Up to month 60
measure: Change from baseline in proteinuria
timeFrame: Up to month 60
measure: Change from baseline in estimated glomerular filtration rate (eGFR)
timeFrame: Up to month 60
measure: Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage
timeFrame: Up to month 60
measure: Percentage of participants achieving maintenance of drug-free DORIS remission
timeFrame: Up to month 60
measure: Percentage of participants achieving maintenance of LLDAS
timeFrame: Up to month 60
measure: Percentage of participants achieving maintenance of SRI-4
timeFrame: Up to month 60
measure: Time from first response to loss of response for drug-free DORIS remission
timeFrame: Up to month 60
measure: Time from first response to loss of response for LLDAS
timeFrame: Up to month 60
measure: Time from first response to loss of response for SRI-4
timeFrame: Up to month 60
measure: Time from baseline to first drug-free DORIS remission
timeFrame: Up to month 60
measure: Time from baseline to LLDAS
timeFrame: Up to month 60
measure: Time from baseline to SRI-4
timeFrame: Up to month 60
measure: Duration of drug-free status
timeFrame: Up to month 60
measure: Percentage of participants achieving DORIS remission regardless of drug-free status
timeFrame: Up to month 60
measure: Glucocorticoid used post-infusion for SLE treatment
timeFrame: Up to month 60
measure: Change of serum autoantibodies from baseline
timeFrame: Up to month 60
measure: Change in complement factor (C3 and C4) levels from baseline
timeFrame: Up to month 60
measure: Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue
timeFrame: Up to month 60
measure: Change from baseline in PRO as assessed by SF 36 v2 Acute
timeFrame: Up to month 60
measure: Change from baseline in PRO as assessed by EQ-5D-5L
timeFrame: Up to month 60
measure: Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain
timeFrame: Up to month 60
measure: Change from baseline in PRO as assessed by PGI-S Fatigue
timeFrame: Up to month 60
measure: Patient Global Impression of Change (PGI-C) Pain
timeFrame: Up to month 60
measure: PGI-C Fatigue
timeFrame: Up to month 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0009
state: Alabama
city: Los Angeles
country: United States
facility: Local Institution - 0038
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0051
state: California
city: Palo Alto
country: United States
facility: Local Institution - 0035
state: California
city: Aurora
country: United States
facility: Local Institution - 0033
state: Colorado
city: Jacksonville
country: United States
facility: Local Institution - 0006
state: Florida
city: Miami
country: United States
facility: Local Institution - 0002
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0008
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0036
state: Florida
city: Zephyrhills
country: United States
facility: Local Institution - 0062
state: Florida
city: Boston
country: United States
facility: Local Institution - 0052
state: Massachusetts
city: Rochester
country: United States
facility: Local Institution - 0011
state: Minnesota
city: Summit
country: United States
facility: Local Institution - 0001
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0040
state: New York
city: New York
country: United States
facility: Local Institution - 0004
state: New York
city: New York
country: United States
facility: Local Institution - 0005
state: New York
city: New York
country: United States
facility: Local Institution - 0039
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0010
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0012
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0003
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0041
state: Oklahoma
city: Dallas
country: United States
facility: Local Institution - 0059
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0007
state: Washington
city: ABB
country: Argentina
facility: Local Institution - 0016
state: Ciudad Autónoma De Buenos Aires
city: ABB
country: Argentina
facility: Local Institution - 0017
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0023
state: Ciudad Autónoma De Buenos Aires
city: Vienna
country: Austria
facility: Local Institution - 0037
state: Wien
city: Salzburg
country: Austria
facility: Local Institution - 0031
city: Leuven
country: Belgium
facility: Local Institution - 0020
state: Vlaams-Brabant
city: Sao Paulo
country: Brazil
facility: Local Institution - 0058
state: São Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 0021
city: São Paulo
country: Brazil
facility: Local Institution - 0022
city: Vancouver
country: Canada
facility: Local Institution - 0048
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0045
state: Ontario
city: Odense
country: Denmark
facility: Local Institution - 0056
state: Syddanmark
city: Copenhagen
country: Denmark
facility: Local Institution - 0047
city: Montpellier
country: France
facility: Local Institution - 0018
state: Hérault
city: Rennes
country: France
facility: Local Institution - 0019
city: Paris
country: France
facility: Local Institution - 0064
state: Île-de-France
city: Köln
country: Germany
facility: Local Institution - 0029
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Local Institution - 0030
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Local Institution - 0028
state: Sachsen
city: Berlin
country: Germany
facility: Local Institution - 0026
city: Erlangen
country: Germany
facility: Local Institution - 0027
city: Ramat Gan
country: Israel
facility: Local Institution - 0043
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Local Institution - 0042
city: Roma
country: Italy
facility: Local Institution - 0025
state: Lazio
city: Milan
country: Italy
facility: Local Institution - 0032
state: Milano
city: Rome
country: Italy
facility: Local Institution - 0044
state: Roma
city: Pisa
country: Italy
facility: Local Institution - 0070
state: Toscana
city: Sapporo
country: Japan
facility: Local Institution - 0055
state: Hokkaido
city: Yokohama
country: Japan
facility: Local Institution - 0072
state: Kanagawa
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0068
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0069
state: Tokyo
city: Chiba
country: Japan
facility: Local Institution - 0067
city: Fukuoka
country: Japan
facility: Local Institution - 0054
city: Okayama
country: Japan
facility: Local Institution - 0063
city: Osaka
country: Japan
facility: Local Institution - 0053
city: Amsterdam
country: Netherlands
facility: Local Institution - 0046
state: Noord-Holland
city: Łódź
country: Poland
facility: Local Institution - 0034
state: Łódzkie
city: Bytom
country: Poland
facility: Local Institution - 0024
state: Śląskie
city: Gliwice
country: Poland
facility: Local Institution - 0049
state: Śląskie
city: Lisbon
country: Portugal
facility: Local Institution - 0013
state: Lisboa
city: Barcelona
country: Spain
facility: Local Institution - 0015
state: Barcelona [Barcelona]
city: Esplugues de Llobregat
country: Spain
facility: Local Institution - 0071
state: Barcelona [Barcelona]
city: Málaga
country: Spain
facility: Local Institution - 0014
city: London
country: United Kingdom
facility: Local Institution - 0060
state: London, City Of
city: London
country: United Kingdom
facility: Local Institution - 0061
state: London, City Of
city: London
country: United Kingdom
facility: Local Institution - 0050
state: London, City Of
city: London
country: United Kingdom
facility: Local Institution - 0057
state: London, City Of
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: