Phase 2 Study of Rapcabtagene Autoleucel in Myositis
Condition(s) studied
Investigational drug(s) / intervention(s)
Rapcabtagene autoleucel: Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.
Active Comparator Option: Investigator choice of treatment as per protocol
Study summary
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
Eligibility
Primary outcome measure(s)
- Proportion of participants achieving moderate- to-major improvement in Total Improvement Score (TIS) at Week 52 — Week 52
The percentage of participants with a TIS of at least 40 at the 52nd week after the start of the study, corresponding to moderate-to-major improvement.
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| University Of Alabama | Birmingham | Alabama | |
| FL Medical Clinic Orlando Health | Zephyrhills | Florida | |
| Augusta University Georgia | Augusta | Georgia | |
| Northwestern University | Chicago | Illinois | |
| University Of Iowa | Iowa City | Iowa | |
| Duke Clinical Research Institute | Durham | North Carolina | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Baylor University Medical Center | Dallas | Texas | |
| Houston Methodist Hospital | Houston | Texas | |
| LDS Hospital | Salt Lake City | Utah | |
| Novartis Investigative Site | Melbourne | Victoria | |
| Novartis Investigative Site | Barretos | São Paulo | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | Brest | France | |
| Novartis Investigative Site | Lille | France | |
| Novartis Investigative Site | Lyon | France | |
| Novartis Investigative Site | Marseille | France | |
| Novartis Investigative Site | Paris | France | |
| Novartis Investigative Site | Rennes | France | |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | |
| Novartis Investigative Site | Leipzig | Saxony | |
| Novartis Investigative Site | Jena | Thuringia | |
| Novartis Investigative Site | Aachen | Germany | |
| Novartis Investigative Site | Hamburg | Germany | |
| Novartis Investigative Site | Mainz | Germany | |
| Novartis Investigative Site | Nuremberg | Germany | |
| Novartis Investigative Site | Ulm | Germany | |
| Novartis Investigative Site | Haifa | Israel | |
| Novartis Investigative Site | Ramat Gan | Israel | |
| Novartis Investigative Site | Tel Aviv | Israel | |
| Novartis Investigative Site | Ancona | AN | |
| Novartis Investigative Site | Brescia | BS | |
| Novartis Investigative Site | Monza | MB | |
| Novartis Investigative Site | Milan | MI | |
| Novartis Investigative Site | Rozzano | MI | |
| Novartis Investigative Site | Verona | VR | |
| Novartis Investigative Site | Sapporo | Hokkaido | |
| Novartis Investigative Site | Yokohama | Kanagawa | |
| Novartis Investigative Site | Sendai | Miyagi |
+ 28 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals 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 NCT06665256 on ClinicalTrials.gov ↗ ← All trials in Spain