A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Condition(s) studied
Investigational drug(s) / intervention(s)
CC-97540: 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 establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
Eligibility
Primary outcome measure(s)
- Number of participants with treatment-emergent adverse events (AEs) in each indication. — Up to 2 years after CC-97540 infusion
- Number of participants with serious AEs (SAEs) in each indication. — Up to 2 years after CC-97540 infusion
- Number of participants with AEs of special interest (AESI) in each indication. — Up to 2 years after CC-97540 infusion
- Number of participants with laboratory abnormalities in each indication. — Up to 2 years after CC-97540 infusion
- Number of participants with Dose Limiting Toxicities (DLT) in each indication. — Up to 2 years after CC-97540 infusion
- Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication. — Up to 2 years after CC-97540 infusion
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0035 | Aurora | Colorado | |
| Local Institution - 0024 | Denver | Colorado | |
| Local Institution - 0006 | Jacksonville | Florida | |
| Local Institution - 0056 | Miami | Florida | |
| Local Institution - 0053 | Chicago | Illinois | |
| Local Institution - 0038 | Boston | Massachusetts | |
| Local Institution - 0033 | Worcester | Massachusetts | |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | |
| Local Institution - 0031 | Ann Arbor | Michigan | |
| Local Institution - 0037 | Detroit | Michigan | |
| Local Institution - 0022 | Rochester | Minnesota | |
| Local Institution - 0010 | St Louis | Missouri | |
| Local Institution - 0028 | Omaha | Nebraska | |
| Local Institution - 0008 | Summit | New Jersey | |
| Local Institution - 0002 | New York | New York | |
| Local Institution - 0011 | New York | New York | |
| Local Institution - 0007 | New York | New York | |
| Local Institution - 0003 | Chapel Hill | North Carolina | |
| Local Institution - 0005 | Cleveland | Ohio | |
| Local Institution - 0036 | Dallas | Texas | |
| Local Institution - 0029 | Houston | Texas | |
| Local Institution - 0034 | Houston | Texas | |
| Local Institution - 0004 | Seattle | Washington | |
| Local Institution - 0057 | Seattle | Washington | |
| Local Institution - 0058 | Seattle | Washington | |
| Local Institution - 0019 | Leuven | Vlaams-Brabant | |
| Local Institution - 0044 | Pessac | Aquitaine | |
| Local Institution - 0015 | Montpellier | Hérault | |
| Local Institution - 0016 | Lille | France | |
| Local Institution - 0040 | Nice | France | |
| Local Institution - 0018 | Paris | France | |
| Local Institution - 0020 | Rennes | France | |
| Local Institution - 0049 | Würzburg | Bavaria | |
| Local Institution - 0042 | Cologne | North Rhine-Westphalia | |
| Local Institution - 0041 | Leipzig | Saxony | |
| Local Institution - 0045 | Magdeburg | Saxony-Anhalt | |
| Local Institution - 0025 | Berlin | Germany | |
| Local Institution - 0047 | Düsseldorf | Germany | |
| Local Institution - 0017 | Erlangen | Germany | |
| Local Institution - 0012 | Rome | Lazio |
+ 6 more sites — see the full list on the official registry below.
On this site
📄 Actemra (tocilizumab) drug profile →More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in Spain
Other trials for the same condition
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 NCT05869955 on ClinicalTrials.gov ↗ ← All trials in Spain