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Набира участници Фаза 1 NCT06201416

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Rheumatoid Arthritis

Спонсор: Sonoma Biotherapeutics, Inc.

Налично на: БГ
Обобщение
This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.
Описание
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
Кой може да участва
Inclusion Criteria: * Body mass index (BMI) \<35 kg/m\^2, inclusive * Adult-onset, moderate-to-severe rheumatoid arthritis (RA) * Moderate-to-severe active disease * Clinical and/or ultrasound evidence of synovitis * Prior inadequate response to or unable to tolerate available RA therapies * Stable doses of RA medications for at least 30 days * Use of highly effective methods of contraception Exclusion Criteria: * Major surgery within 12 weeks prior to screening or planned within 12 months after dosing * Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * Recurrent infections or active infection * Active or untreated latent tuberculosis * Primary or secondary immunodeficiency * History of or current inflammatory joint disease other than RA
Интервенции
SBT777101
BIOLOGICAL
Места на провеждане 8
САЩ (8)
University of Colorado
Aurora , Colorado
Tufts University
Boston , Massachusetts
Massachusetts General Hospital
Boston , Massachusetts
Brigham and Women's Hospital
Boston , Massachusetts
Northwestern University
Chicago , Illinois
UCSF Medical Center
San Francisco , California
Mayo Clinic
Scottsdale , Arizona
Stanford Medical Center
Stanford , California
Uma Vilas Ayachit
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
06.03.2024
Крайна дата
01.11.2026
Регистрационен номер
NCT06201416
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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