This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of 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 DLBCL. (SOUNDTRACK-B)

Astrazeneca K.K0 个研究点目标入组 20 人开始时间: 2025年1月7日最近更新: 2025年6月11日

试验速览

暂无简介。

•Aged 18 to 80 years old
•Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (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 or more, platelets 75,000/mm3 or more, hemoglobin 9 g/dL or more.
•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 less
•Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible
•Adequate renal function: creatinine clearance (CrCl) of 45 mL/min or more

•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, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
•Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy or autologous
•Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, or prior allogeneic HSCT within 24 weeks of first dose of AZD0486
•Requires chronic immunosuppressive therapy
•Unresolved non hematological AEs Grade 2 or more from prior therapies; history of Grade 3 or more CRS or neurotoxicity from prior CAR-T or TCE therapy
•History of major cardiac abnormalities.
•If female, participant must not be pregnant or breastfeeding.

ORR

defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC

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