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 B-Cell Non-Hodgkin Lymphoma
B-cell Non Hodgkin Lymphoma
Phase 1
No
AZD0486 IV
All
317
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2025 by AstraZeneca
AstraZeneca
N/A
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 B-cell non-Hodgkin lymphoma (B-NHL).
This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.
Location
Status
Location
Seoul, Republic of Korea, 06591
Status
Recruiting
Location
Louisville, KY, United States, 40207
Status
Recruiting
Location
Tampa, FL, United States, 33612
Status
Recruiting
Location
Pittsburgh, PA, United States, 15237
Status
Recruiting
Location
Seoul, Republic of Korea, 05505
Status
Recruiting
Location
Milwaukee, WI, United States, 53226
Status
Recruiting
Location
Columbus, OH, United States, 43210
Status
Recruiting
Location
Seoul, Republic of Korea, 120-752
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: AZD0486 Monotherapy Dose Escalation in Subjects with 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 administered weekly during cycle 1 before reaching the target dose. Additional cohorts may be opened where subjects receive weekly dosing during Cycles 1-2. 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 |
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