Actively Recruiting
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-04-30
125
Participants Needed
28
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
CONDITIONS
Official Title
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic lupus erythematosus (SLE) by 2019 ACR/EULAR criteria with positive antibodies and active disease
- Inadequate response or intolerance to steroids and immunosuppressive therapies for SLE
- Diagnosis of severe, refractory inflammatory myopathy (IIM) by 2017 ACR/EULAR criteria with active disease
- Inadequate response to steroids and prior immunosuppressive therapies for IIM
- Diagnosis of systemic sclerosis (SSc) by 2013 ACR/EULAR criteria with progressive disease
- Inadequate response or intolerance to prior therapies for SSc
- Diagnosis of difficult to treat rheumatoid arthritis (RA) by 2010 ACR/EULAR criteria with active disease
- Inadequate response or intolerance to standard RA therapies
You will not qualify if you...
- Any other systemic autoimmune disease
- Pregnant or nursing women
- Active hepatitis B, C, or HIV infection
- Prior history of malignancies
- Uncontrolled or active infections
- Certain cardiovascular conditions within 6 months before screening
- Previous CAR-T cell therapy
- Significant lung impairment
- Inadequate organ function
- Active, clinically significant central nervous system disorders
- For SLE: drug-induced SLE or other autoimmune diseases alongside SLE
- For IIM: other myopathies or severe muscle damage
- For SSc: pulmonary arterial hypertension requiring treatment or rapidly worsening disease or severe kidney disease
- For RA: additional autoimmune diseases along with RA
- Other protocol-defined inclusion or exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Local Institution - 0041
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Local Institution - 0037
Durham, North Carolina, United States, 27705-2771
Not Yet Recruiting
3
Local Institution - 0007
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
4
Local Institution - 0008
Brisbane, Queensland, Australia, 4029
Withdrawn
5
Local Institution - 0013
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
6
Local Institution - 0040
Salvador, Estado de Bahia, Brazil, 41253-190
Not Yet Recruiting
7
Local Institution - 0039
Porto Alegre, Brazil, 0
Not Yet Recruiting
8
Local Institution - 0038
São Paulo, Brazil, 01508-010
Not Yet Recruiting
9
Local Institution - 0004
Prague, Praha 5, Czechia, 150 06
Not Yet Recruiting
10
Revmatologicky ustav
Prague, Czechia, 12850
Actively Recruiting
11
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, France, 67098
Actively Recruiting
12
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France, 59037
Actively Recruiting
13
Local Institution - 0023
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Not Yet Recruiting
14
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
15
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany, 10117
Actively Recruiting
16
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany, 01307
Actively Recruiting
17
Local Institution - 0031
Hamburg, Germany, 20246
Not Yet Recruiting
18
Sheba Medical Center
Ramat Gan, Central District, Israel, 5262100
Actively Recruiting
19
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
20
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
21
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, Poland, 41-902
Actively Recruiting
22
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach
Gliwice, Silesian Voivodeship, Poland, 44-100
Actively Recruiting
23
Local Institution - 0017
Lodz, Łódź Voivodeship, Poland, 93-513
Not Yet Recruiting
24
ARENSIA Exploratory Medicine
Cluj-Napoca, Cluj, Romania, 400015
Actively Recruiting
25
Fundeni Clinical Institute
Bucharest, Romania, 022328
Actively Recruiting
26
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
27
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
28
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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