Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-04-29
227
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0486, a bispecific antibody that targets CD19 and CD3 to engage T-cells in fighting malignant B cells, in people with B-cell non-Hodgkin lymphoma (B-NHL). This phase 1 study focuses on assessing the safety, tolerability, how the drug moves through and acts in the body, and its clinical activity. The study includes different types of B-NHL such as diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma. AZD0486 is given as an intravenous infusion on days 1 and 15 of each 28-day cycle for up to two years or until treatment stops. Some participants may receive initial priming or step-up doses weekly during the first cycle before reaching the target dose, with additional groups receiving weekly dosing during the first two cycles. Participants are monitored with PET/CT scans to assess disease progression. Those who achieve two consecutive complete responses after six cycles may switch to monthly dosing. Participants will have regular safety and disease assessments throughout the study, including monitoring for side effects and measuring drug levels in the blood. Researchers will evaluate dose-limiting toxicities, adverse events, and key pharmacokinetic measures within specific timeframes. The study also tracks anti-lymphoma activity over a period of up to 48 months. Participation may last up to two years, with follow-up assessments after treatment ends to monitor ongoing effects and safety.
CONDITIONS
Brief Title
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or follicular lymphoma
- For relapsed/refractory cohorts, at least 2 prior therapies received and not candidates for known effective treatments; CAR T-naive allowed if declined, ineligible, or no timely access to CAR T
- For first-line follicular lymphoma cohorts, biopsy-proven Grade 1-3a follicular lymphoma, Stage II-IV, requiring treatment per GELF criteria; prior radiation allowed if more than 14 days before first dose
- ECOG Performance Status of 2 or less
- Adequate liver, bone marrow, and kidney function (eGFR 50 mL/min or higher)
- Locally confirmed CD19 positivity after progression from last CD19-targeted therapy if received
- At least 1 measurable disease site
- ANC 1000/mm3 or higher, platelets 50,000/mm3 or higher, hemoglobin 8.0 g/dL or higher; stable counts after transfusion/growth factor for 72 hours prior to screening
- Total bilirubin less than 1.5 times upper limit of normal, AST/ALT less than 3 times upper limit of normal
You will not qualify if you...
- Diagnosed or treated for another malignancy that may interfere with safety or efficacy assessment
- Active central nervous system involvement by B-cell non-Hodgkin lymphoma; history of CNS involvement allowed if treated and no recurrence within 6 months
- History of leukemic presentation of B-cell non-Hodgkin lymphoma (more than 5,000 circulating lymphoma cells per microliter)
- History or presence of significant CNS pathology
- CNS involvement from active or history of autoimmune disease
- Received CD19 CAR T therapy within 3 months prior to first dose
- Experienced Grade 3 or higher cytokine release syndrome after prior T-cell engager or CAR T therapy
- Experienced Grade 2 or higher neurotoxicity or immune effector cell-associated neurotoxicity syndrome after prior T-cell engager or CAR T therapy
- Received peripheral autologous stem cell transplant within 12 weeks or allogeneic stem cell transplant within 1 year before first dose, or ongoing immunosuppressive therapy post-transplant
- HIV infection or active/chronic hepatitis B or C infections, except if controlled or cured as specified
- History of major cardiac abnormalities
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Cycle 1 (28 days)
Participants may receive priming or step-up dosing weekly during the first cycle before reaching the target dose.
Weekly visits during Cycle 1
Duration - Up to 2 years
Participants receive AZD0486 monotherapy intravenously on day 1 and 15 of 28-day cycles for up to 2 years or until discontinuation criteria are met. Some cohorts may receive weekly dosing during Cycles 1 and 2. Participants are monitored for safety and efficacy with periodic disease assessments.
Infusions on day 1 and 15 of each 28-day cycle, with additional weekly visits depending on cohort during initial cycles
Duration - 90 days
Participants are monitored for safety and clinical outcomes for 90 days after the end of treatment.
Periodic visits for safety assessments
Trial Site Locations
Total: 27 locations
1
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
2
Research Site
Louisville, Kentucky, United States, 40207
Actively Recruiting
3
Research Site
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
4
Research Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
5
Research Site
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Research Site
Portland, Oregon, United States, 97239
Withdrawn
7
Research Site
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
8
Research Site
Austin, Texas, United States, 78704
Actively Recruiting
9
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
10
Research Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
11
Research Site
Bedford Park, Australia, 5042
Withdrawn
12
Research Site
Heidelberg, Australia, 3084
Actively Recruiting
13
Research Site
Hobart, Australia, 7000
Actively Recruiting
14
Research Site
Melbourne, Australia, 3004
Actively Recruiting
15
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
16
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
17
Research Site
Nagoya, Japan, 460-0001
Actively Recruiting
18
Research Site
Yamagata, Japan, 990-9585
Actively Recruiting
19
Research Site
Seoul, South Korea, 03080
Actively Recruiting
20
Research Site
Seoul, South Korea, 05505
Actively Recruiting
21
Research Site
Seoul, South Korea, 06351
Actively Recruiting
22
Research Site
Seoul, South Korea, 06591
Actively Recruiting
23
Research Site
Seoul, South Korea, 120-752
Actively Recruiting
24
Research Site
Kaohsiung City, Taiwan, 833401
Actively Recruiting
25
Research Site
Kweishan, Taiwan, 333
Actively Recruiting
26
Research Site
Tainan, Taiwan, 704
Actively Recruiting
27
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here