A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
Condition(s) studied
Investigational drug(s) / intervention(s)
BMS-986515: Specified dose on specified days
Fludarabine: Specified dose on specified days
Cyclophosphamide: Specified dose on specified days
Tocilizumab: Specified dose on specified days
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number of participants with treatment-emergent adverse events (TEAEs) — Up to 24 months post BMS-986515 infusion
All participants - Number of participants with serious AEs (SAEs) — Up to 24 months post BMS-986515 infusion
All participants - Number of participants with AEs of special interest (AESIs) — Up to 24 months post BMS-986515 infusion
All participants - Number of participants with laboratory abnormalities — Up to 24 months post BMS-986515 infusion
All participants - Number of participants with Dose-Limiting Toxicities (DLTs) — Up to 24 months post BMS-986515 infusion
All participants - Number of participants with DLTs that occur during the DLT evaluation period — 28 days post-BMS-986515 infusion
All participants
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Brigham And Womens Hospital | Boston | Massachusetts | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| Local Institution - 0007 | Camperdown | New South Wales | Withdrawn |
| Local Institution - 0008 | Brisbane | Queensland | Withdrawn |
| Local Institution - 0013 | Clayton | Victoria | Withdrawn |
| Local Institution - 0040 | Salvador | Estado de Bahia | Not Yet Recruiting |
| Local Institution - 0039 | Porto Alegre | Brazil | Not Yet Recruiting |
| Local Institution - 0038 | São Paulo | Brazil | Not Yet Recruiting |
| Local Institution - 0004 | Prague | Praha 5 | Not Yet Recruiting |
| Revmatologicky ustav | Prague | Czechia | Recruiting |
| CHU Strasbourg-Hautepierre | Strasbourg | Alsace | Recruiting |
| Hopital Claude Huriez - CHU de Lille | Lille | Nord | Recruiting |
| Universitaetsklinikum Duesseldorf | Düsseldorf | North Rhine-Westphalia | Recruiting |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel | Kiel | Schleswig-Holstein | Recruiting |
| Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin | Berlin | Germany | Recruiting |
| Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Germany | Recruiting |
| Local Institution - 0031 | Hamburg | Germany | Withdrawn |
| Sheba Medical Center | Ramat Gan | Central District | Recruiting |
| Hadassah Medical Center | Jerusalem | Israel | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | Recruiting |
| Szpital Specjalistyczny nr 1 w Bytomiu | Bytom | Silesian Voivodeship | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach | Gliwice | Silesian Voivodeship | Recruiting |
| Local Institution - 0017 | Lodz | Łódź Voivodeship | Withdrawn |
| ARENSIA Exploratory Medicine | Cluj-Napoca | Cluj | Recruiting |
| Fundeni Clinical Institute | Bucharest | Romania | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [Cataluña] | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | Recruiting |
On this site
📄 Actemra (tocilizumab) drug profile →More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07115745 on ClinicalTrials.gov ↗ ← All trials in Poland