Descartes-08 in Autoantibody Myositis
A legfontosabb adatok
- Hol
- Austin, Boston, Chapel Hill és Orange (Egyesült Államok)Mind a 4 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- National Neuromuscular Research InstituteAustin, Egyesült ÁllamokContact: Cartesian TherapeuticsRésztvevőt keres
- Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Cartesian TherapeuticsRésztvevőt keres
- University of North CarolinaChapel Hill, Egyesült ÁllamokContact: Cartesian TherapeuticsRésztvevőt keres
- University of California IrvineOrange, Egyesült ÁllamokContact: Cartesian TherapeuticsRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Cartesian Therapeutics
- Azonosító
- NCT07391605
- A regiszteradat frissítve
- 2026. augusztus 17.
- Eredeti leírás
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).A teljes eredeti leírásKevesebb
A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).
Bevonási feltételek: Confirmed diagnosis of one of the following:; Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)."; Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement; Refractory or intolerance to standard therapy; Stable background immunosuppressive therapy for ≥8 weeks; Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air); Informed consent, compliance with visits, contraception, and vaccinations required.
Kizáró feltételek: Isolated interstitial lung disease (ILD) without muscle or skin involvement; Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound); Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension; Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's); Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression; Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation; Pregnancy or lactation; Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods); Live vaccination within 4 weeks; History of primary immunodeficiency, organ or bone marrow transplant; Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.