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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07115745




Registration number
NCT07115745
Ethics application status
Date submitted
7/02/2025
Date registered
11/08/2025
Date last updated
11/08/2025

Titles & IDs
Public title
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
Scientific title
A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases
Secondary ID [1] 0 0
2024-517681-41
Secondary ID [2] 0 0
IM060-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BMS-986515
Treatment: Drugs - Fludarabine
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Tocilizumab

Experimental: BMS-986515 Administration -


Treatment: Other: BMS-986515
Specified dose on specified days

Treatment: Drugs: Fludarabine
Specified dose on specified days

Treatment: Drugs: Cyclophosphamide
Specified dose on specified days

Treatment: Drugs: Tocilizumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 24 months post BMS-986515 infusion
Primary outcome [2] 0 0
Number of participants with serious AEs (SAEs)
Timepoint [2] 0 0
Up to 24 months post BMS-986515 infusion
Primary outcome [3] 0 0
Number of participants with AEs of special interest (AESIs)
Timepoint [3] 0 0
Up to 24 months post BMS-986515 infusion
Primary outcome [4] 0 0
Number of participants with laboratory abnormalities
Timepoint [4] 0 0
Up to 24 months post BMS-986515 infusion
Primary outcome [5] 0 0
Number of participants with Dose-Limiting Toxicities (DLTs)
Timepoint [5] 0 0
Up to 24 months post BMS-986515 infusion
Primary outcome [6] 0 0
Number of participants with DLTs that occur during the DLT evaluation period
Timepoint [6] 0 0
28 days post-BMS-986515 infusion
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Area under the concentration-time curve (AUC)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24
Timepoint [5] 0 0
Up to Week 24
Secondary outcome [6] 0 0
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24
Timepoint [6] 0 0
Up to Week 24
Secondary outcome [7] 0 0
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24
Timepoint [7] 0 0
Up to Week 24
Secondary outcome [8] 0 0
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24
Timepoint [8] 0 0
Up to Week 24
Secondary outcome [9] 0 0
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24
Timepoint [9] 0 0
Up to Week 24
Secondary outcome [10] 0 0
Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline
Timepoint [10] 0 0
Up to Week 24
Secondary outcome [11] 0 0
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline
Timepoint [11] 0 0
Up to Week 24
Secondary outcome [12] 0 0
Number of participants who achieve an minimal clinically important differences in SSc (MCID) from baseline of the modified Rodnan Skin Score (mRSS) at Week 24
Timepoint [12] 0 0
Up to Week 24
Secondary outcome [13] 0 0
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24
Timepoint [13] 0 0
Up to Week 24
Secondary outcome [14] 0 0
Number of participants with low disease activity at Week 24 from baseline
Timepoint [14] 0 0
Up to Week 24

Eligibility
Key inclusion criteria
- Systemic lupus erythematosus (SLE) population:.

i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).

ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody.

iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.

iv) Participants must have active disease at screening.

- Inflammatory myopathy (IIM) population:.

i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.

ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.

iv) Evidence of active disease.

- Systemic sclerosis (SSc) population:.

i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.

ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease.

- Rheumatoid arthritis (RA) population:.

i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- All participants:.

i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening.

vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.

* SLE population:.

i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
* IIM population:.

i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
* SSc population:.

i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.

ii) Rapidly deteriorating SSc, or history of severe kidney disease.

* RA population:.

i) People who have additional autoimmune diseases along with RA.
* Other protocol-defined inclusion/exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
23/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/08/2030
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0007 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0008 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0013 - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Washington
Country [4] 0 0
Brazil
State/province [4] 0 0
Estado de Bahia
Country [5] 0 0
Brazil
State/province [5] 0 0
Porto Alegre
Country [6] 0 0
Brazil
State/province [6] 0 0
São Paulo
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 5
Country [8] 0 0
Czechia
State/province [8] 0 0
Prague
Country [9] 0 0
France
State/province [9] 0 0
Alsace
Country [10] 0 0
France
State/province [10] 0 0
Nord
Country [11] 0 0
Germany
State/province [11] 0 0
North Rhine-Westphalia
Country [12] 0 0
Germany
State/province [12] 0 0
Schleswig-Holstein
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Dresden
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Israel
State/province [16] 0 0
Central District
Country [17] 0 0
Israel
State/province [17] 0 0
Tell Abib
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Poland
State/province [19] 0 0
Pomeranian Voivodeship
Country [20] 0 0
Poland
State/province [20] 0 0
Silesian Voivodeship
Country [21] 0 0
Poland
State/province [21] 0 0
Lódz Voivodeship
Country [22] 0 0
Romania
State/province [22] 0 0
Bucure?ti
Country [23] 0 0
Romania
State/province [23] 0 0
Cluj
Country [24] 0 0
Romania
State/province [24] 0 0
Bucharest
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona [Barcelona]
Country [26] 0 0
Spain
State/province [26] 0 0
Catalunya [Cataluña]
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid, Comunidad de

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
8559073286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07115745