Study identifier:D7400C00006
ClinicalTrials.gov identifier:NCT04594642
EudraCT identifier:N/A
CTIS identifier:N/A
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
B-cell Non Hodgkin Lymphoma
Phase 1
No
AZD0486 IV
All
116
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
N/A
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD0486 Monotherapy Dose Escalation in Subjects with RR B-NHL AZD0486 monotherapy will be administered intravenously on day 1 and 15 of 28 day cycles for a maximum of 2 years or until discontinuation criteria are met. Depending on cohort, subjects may receive priming or step-up dosing during cycle 1 before reaching the target dose. While on study, subjects will be monitored for safety and efficacy with periodic disease assessment with PET/CT. If subject achieves two consecutive CRs after completing C6, then they may be eligible for monthly dosing | Drug: AZD0486 IV AZD0486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells leading to T cell-mediated cytotoxicity of malignant B cells Other Name: TNB-486 |