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Набира участници Фаза 2 NCT06526793

Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

Фаза 2 – изследване на ефективността и дозировката
Заболявания: B-cell Non-Hodgkin Lymphoma Follicular Lymphoma (FL) Large B-Cell Lymphoma (LBCL)

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.
Описание
This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of Surovatamig (AZD0486) monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.
Кой може да участва
1. Key Inclusion Criteria: * Aged 18 years old and above * Histologically confirmed relapsed refractory FL (Module 1) and LBCL (Module 2) after at least 2 prior lines of therapy * ECOG performance status 0 to 2 * Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy * FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \> 1.5 cm in its longest dimension), or extranodal lesion (defined as \> 1.0 cm in its longest dimension) * Adequate hematological function: ANC ≥ 1000/mm3, platelets * 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening * Adequate liver function: total bilirubin \<1.5x ULN, AST/ALT ≤ 3xULN or \< 5 × ULN in the presence of lymphoma involvement of the liver * Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA The above is a summary, other inclusion criteria details may apply. 2. Key Exclusion Criteria: * Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation * Active CNS involvement by B-NHL * Leukemic presentation of B-NHL * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis or other severe mental illness * Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig * Requires chronic immunosuppressive therapy * Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy * History of major cardiac abnormalities. * If female, participant must not be pregnant or breastfeeding. The above is a summary, other exclusion criteria details may apply.
Места на провеждане 15
Австралия (1)
Research Site
Heidelberg
Бразилия (1)
Research Site
Porto Alegre
SUSPENDED
Канада (1)
Research Site
Barrie , Ontario
NOT_YET_RECRUITING
Китай (1)
Research Site
Chengdu
Дания (1)
Research Site
Aalborg
WITHDRAWN
Франция (1)
Research Site
Montpellier
Hong Kong (1)
Research Site
Hong Kong
Италия (1)
Research Site
Alessandria
Япония (1)
Research Site
Chiba
Южна Корея (1)
Research Site
Seoul
Испания (1)
Research Site
Barcelona
Швеция (1)
Research Site
Gothenburg
Taiwan (1)
Research Site
Kaohsiung City
WITHDRAWN
Великобритания (1)
Research Site
London
САЩ (1)
Research Site
Phoenix , Arizona
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
27.11.2024
Крайна дата
14.06.2029
Регистрационен номер
NCT06526793
Източник
anzctr
Запитване за медицински туризъм

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