Brief Summary
This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses, in subjects with relapsed or refractory B-cell non-Hodgkin lymphomacancers of the lymphatic system (B-NHL) who have received 2 or more prior lines of therapy.
Intervention / Treatment
- Drug: AZD0486 IV
Inclusion Criteria:
- Biopsyremoval of a section of tissue to analyse for cancer cells proven B-NHL, including DLBCL, HGBL, or FL.-. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in B-NHL. CAR T-naive subjects are allowed if they have declined, are considered ineligible for, or do not have timely access to CAR T cell therapies.
- Subject has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of ≤ 2.
- Subject must have adequate liver, bone marrowsoft, spongy tissue found in bones that makes blood cells and kidneya pair of bean-shaped organs in the abdomen that are responsible for filtering excess water and waste products from the blood and converting them into urine to be removed from the body function (eGFR ≥ 50 mL/min).
- Subject must have locally confirmed CD19 positivity (must be documented after time of progression from last CD19-targeted therapy, if received)
- Subject must have at least 1 measurable disease site
- Subject must have ANC >/= 1000/mm3, plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding >/= 50,000 mm3, hemoglobin >/= 8.0 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening
- Subject must have a total bilirubin <1.5x ULN, AST/ALT < 3xULN