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Активно (без набиране) Фаза 1 NCT06660563

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Lymphoma, Non-Hodgkin

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
Кой може да участва
Inclusion Criteria: * Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy * Participants must have measurable disease as defined by the appropriate disease response criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug * Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: * Known active central nervous system involvement (CNS) or leptomeningeal involvement * Prior solid-organ transplantation * Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug * Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade \<= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2) * Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation * Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
Места на провеждане 4
Австралия (1)
Concord Hospital
Concord
Испания (1)
Hosp Univ Vall D Hebron
Barcelona
Taiwan (1)
China Medical University Hospital
Taichung
Великобритания (1)
University Hospitals Of Leicester Nhs Trust
Leicester
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
22.10.2024
Крайна дата
21.09.2026
Регистрационен номер
NCT06660563
Източник
anzctr
Запитване за медицински туризъм

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