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Recruiting Phase 2 NCT06526793

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

Phase 2 – studying effectiveness and dosage
Conditions: B-cell Non-Hodgkin Lymphoma Follicular Lymphoma (FL) Large B-Cell Lymphoma (LBCL)

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
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.
Locations 15
Australia (1)
Research Site
Heidelberg
Brazil (1)
Research Site
Porto Alegre
SUSPENDED
Canada (1)
Research Site
Barrie , Ontario
NOT_YET_RECRUITING
China (1)
Research Site
Chengdu
Denmark (1)
Research Site
Aalborg
WITHDRAWN
France (1)
Research Site
Montpellier
Hong Kong (1)
Research Site
Hong Kong
Italy (1)
Research Site
Alessandria
Japan (1)
Research Site
Chiba
South Korea (1)
Research Site
Seoul
Spain (1)
Research Site
Barcelona
Sweden (1)
Research Site
Gothenburg
Taiwan (1)
Research Site
Kaohsiung City
WITHDRAWN
United Kingdom (1)
Research Site
London
United States (1)
Research Site
Phoenix , Arizona
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
27.11.2024
Completion date
14.06.2029
Registry ID
NCT06526793
Source
anzctr
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