Last updated 19 days ago

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

240 patients around the world

Available in Brazil

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of 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 to 80 years of age with relapsed or refractory B-NHL.

AstraZeneca

240Patients around the world

This study is for people with

Non-Hodgkin Lymphoma

Diffuse large B-cell lymphoma

Large B-cell lymphoma

Follicular lymphoma

Requirements for the patient

To 80 Years

All Gender

Medical requirements

: Aged 18 to 80 years old.
Histologically confirmed relapsed refractory FL and DLBCL 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. 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.

: 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 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.

StudySOUNDTRACK-B

SponsorAstraZeneca

Conditions

Diffuse large B-cell lymphomaLarge B-cell lymphomaFollicular lymphoma

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06526793