RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
A legfontosabb adatok
- Hol
- Ann Arbor, Atlanta, Aurora, Bethesda, Boston, Chapel Hill, Chicago, Dallas, Durham, Houston, Jacksonville, Kansas City, Milwaukee, Nashville, New York, Orange, Philadelphia, Pittsburgh, Portland, Rochester, Salt Lake City, San Francisco, Seattle, St. Petersburg és The Bronx (Egyesült Államok)Mind a 31 helyszín megnézése
- Fázis
- 2/3. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 6 és 75 év között vagy?
Forrás: NCT06154252: ki vehet részt
Helyszínek itt: Egyesült Államok
- University of Michigan - Accepting Young Adult and Juvenile PatientsAnn Arbor, Egyesült ÁllamokContact: Abigail WhalenRésztvevőt keres
- Children's Healthcare of Atlanta - Accepting Juvenile PatientsAtlanta, Egyesült ÁllamokContact: Judson RussellRésztvevőt keres
- Emory University - Accepting Adult PatientsAtlanta, Egyesült ÁllamokContact: John VargheseRésztvevőt keres
- Children's Hospital Colorado - Accepting Juvenile PatientsAurora, Egyesült ÁllamokRésztvevőt keres
- National Institutes of Health - Accepting Adult and Juvenile PatientsBethesda, Egyesült ÁllamokContact: Julie ThompsonRésztvevőt keres
- Boston Children's Hospital - Accepting Young Adults and Juvenile PatientsBoston, Egyesült ÁllamokContact: Kyle McBreartyRésztvevőt keres
- University of North Carolina at Chapel Hill - Accepting Adult PatientsChapel Hill, Egyesült ÁllamokContact: Leah LuizzaRésztvevőt keres
- Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile PatientsChicago, Egyesült ÁllamokContact: Tyler SorensenRésztvevőt keres
- Northwestern Memorial Hospital - Accepting Adult PatientsChicago, Egyesült ÁllamokContact: Kaitlin KingRésztvevőt keres
- The University of Chicago Medical Center - Accepting Adult and Juvenile PatientsChicago, Egyesült ÁllamokContact: Dr. Iazsmin Ventura, MD (principal investigator)Résztvevőt keres
- University of Texas Southwestern Medical Center - Accepting Juvenile PatientsDallas, Egyesült ÁllamokContact: Dr. Samuel JohnRésztvevőt keres
- Duke University Medical Center - Accepting Young Adults and Juvenile PatientsDurham, Egyesült ÁllamokContact: Lynn Rodgers, MSRésztvevőt keres
- Houston Methodist Hospital - Accepting Adult PatientsHouston, Egyesült ÁllamokContact: Amelia A. Nounes, MSN, RN, CCRPRésztvevőt keres
- University of Texas MD Anderson Cancer Center - Accepting Adult PatientsHouston, Egyesült ÁllamokContact: Christina Amos Briggs, BSN, RNRésztvevőt keres
- Mayo Clinic Florida - Accepting Adult PatientsJacksonville, Egyesült ÁllamokContact: Gabrielle PariseauRésztvevőt keres
- University of Kansas Medical Center - Accepting Adult PatientsKansas City, Egyesült ÁllamokContact: Samantha ColganRésztvevőt keres
- Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile PatientsMilwaukee, Egyesült ÁllamokContact: Erin Hammelev - Research CoordinatorToborzás még nem indult
- Vanderbilt University Medical Center - Accepting Adult PatientsNashville, Egyesült ÁllamokContact: Tofi SoneyeRésztvevőt keres
- Hospital for Special Surgery - Accepting Adult and Juvenile PatientsNew York, Egyesült ÁllamokContact: Janvi BhatiaRésztvevőt keres
- Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile PatientsNew York, Egyesült ÁllamokContact: Atifah OsratRésztvevőt keres
- University of California Irvine - Accepting Adult PatientsOrange, Egyesült ÁllamokContact: Alpha ClinicRésztvevőt keres
- Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile PatientsPhiladelphia, Egyesült ÁllamokContact: Dr. Caitlin Elgarten, MD, MSCE (principal investigator)Résztvevőt keres
- UPMC Arthritis and Autoimmunity Center - Accepting Adult PatientsPittsburgh, Egyesült ÁllamokContact: Carol OrissRésztvevőt keres
- UPMC Children's Hospital of Pittsburgh - Accepting Juvenile PatientsPittsburgh, Egyesült ÁllamokContact: Vibha Chauhan, PhDRésztvevőt keres
- Oregon Health & Science University - Accepting Adult PatientsPortland, Egyesült ÁllamokContact: Katie LewisRésztvevőt keres
- Mayo Clinic - Accepting Adult PatientsRochester, Egyesült ÁllamokContact: Bridget NejaRésztvevőt keres
- Primary Children's Hospital/University of Utah - Accepting Juvenile PatientsSalt Lake City, Egyesült ÁllamokContact: Morgan Badgley - Research CoordinatorRésztvevőt keres
- University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile PatientsSan Francisco, Egyesült ÁllamokContact: Zilan ZhengRésztvevőt keres
- Seattle Children's Research Institute - Accepting Juvenile PatientsSeattle, Egyesült ÁllamokContact: Dr. Susan Shenoi, MD, MSRésztvevőt keres
- Johns Hopkins All Children's Hospital - Accepting Juvenile PatientsSt. Petersburg, Egyesült ÁllamokContact: Laura EscobarRésztvevőt keres
- Children's Hospital at Montefiore - Accepting Young Adult and Juvenile PatientsThe Bronx, Egyesült ÁllamokContact: Emily GilliesRésztvevőt 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
- Cabaletta Bio
- Azonosító
- NCT06154252EU 2025-521145-24-01
- A regiszteradat frissítve
- 2026. október 15.
- Eredeti leírás
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory MyopathyA teljes eredeti leírásKevesebb
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
Bevonási feltételek: Age ≥18 and ≤75; A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria; Diagnosis of DM, ASyS, or IMNM; Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography; Presence of muscle weakness; Other protocol-defined criteria apply; Age ≥6 and ≤17 years at enrollment; A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria; Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography; Other protocol-defined criteria apply.
Kizáró feltételek: Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures; Previous CAR T cell therapy; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Other protocol-defined criteria apply; Juvenile Cohort; Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures; Previous CAR T cell therapy; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Other protocol-defined criteria apply; History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites; Active infection requiring medical intervention at screening; Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections; Significant lung or cardiac impairment; History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites; Active infection requiring medical intervention at screening; Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections; Significant lung or cardiac impairment; Contraindication to leukapheresis; Contraindication to leukapheresis.
Adult Cohorts.