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Активно (без набиране) Фаза 1 NCT05784441

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: * can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients. * will JNJ-90009530 help patients achieve a response and for how long?
Кой може да участва
Key Inclusion Criteria * Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent * All participants must have relapsed or refractory disease for each histologic subtype * Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have \>= 2 lines of systemic therapy or \>=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent * Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have \>=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody * Tumor must be cluster of differentiation (CD) 20 positive * Measurable disease as defined by Lugano 2014 classification * Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 Key Exclusion Criteria * Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL) * Prior allogeneic Hematopoietic stem cell transplantation (HSCT) * Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion * Uncontrolled active infections * History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis \[DVT\]) * History of stroke, unstable angina, myocardial infarction, congestive heart failure ( New York Heart Association \[NYHA\] Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening * History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder * Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system * Active central nervous system (CNS) involvement by malignancy * Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
Места на провеждане 4
Австралия (1)
Royal Prince Alfred Hospital
Camperdown
Израел (1)
Hadassah Medical Center
Jerusalem
Великобритания (1)
University College London Hospitals
London
САЩ (1)
University of Iowa Hospital
Iowa City , Iowa
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
06.11.2023
Крайна дата
03.01.2040
Регистрационен номер
NCT05784441
Източник
anzctr
Запитване за медицински туризъм

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