Spots Global Cancer Trial Database for A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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Trial Identification

Brief Title: A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Official Title: A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AZD0486, a Bispecific Antibody Targeting CD19 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Study ID: NCT04594642

Conditions

B-cell Non Hodgkin Lymphoma

Diffuse Large B Cell Lymphoma

High-grade B-cell Lymphoma

Follicular Lymphoma

Interventions

AZD0486 IV

Study Description

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 antibody, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) who have received 2 or more prior lines of therapy.

Detailed Description: The study consists of 3 parts. Part 1 Arm A is a dose escalation study allowing the assessment of safety, tolerability, PK and PD profiles of single-agent AZD0486. Part 2 Arm B will evaluate the MTD (or RP2D) of AZD0486 monotherapy in subjects with biopsy proven RR DLBCL and HGBL. This will be initiated once expansion dose has been selected based on data from Part 1 Arm A. Part 2 Arm C evaluate the MTD (or RP2D) of AZD0486 monotherapy in subjects with biopsy proven RR FL. Arm C will be initiated once the expansion dose for FL has been selected based on data from the Monotherapy Dose Escalation (Part 1, Arm A). The expansion dose and dosing frequency for Part 2 will be chosen by the SMG based on safety, tolerability, and PK/PD data collected during the dose escalation portion of the study.