Actively Recruiting
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
Led by AstraZeneca · Updated on 2026-04-29
227
Participants Needed
27
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 groups, at least 2 prior therapies received and not candidates for treatments known to benefit B-NHL. CAR T-naive patients allowed if ineligible or declined CAR T therapy.
- For first-line follicular lymphoma group, biopsy-proven Grade 1-3a follicular lymphoma stage II-IV requiring treatment based on GELF criteria; prior localized radiation allowed if more than 14 days before first dose.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
- Adequate liver, bone marrow, and kidney function with eGFR 50 mL/min or higher.
- Locally confirmed CD19 positivity after progression from last CD19-targeted therapy if applicable.
- At least one measurable disease site.
- Absolute neutrophil count (ANC) of 1000/mm3 or higher, platelets 50,000/mm3 or higher, hemoglobin 8.0 g/dL or higher; transfusions or growth factors allowed if counts stable for 72 hours before screening.
- Total bilirubin less than 1.5 times upper limit of normal (ULN); AST and ALT less than 3 times ULN.
You will not qualify if you...
- Diagnosis or treatment for another malignancy that may interfere with safety or efficacy assessments.
- Active central nervous system (CNS) involvement by B-cell non-Hodgkin lymphoma; distant history of CNS involvement allowed if treated and no recurrence within 6 months.
- History of leukemic presentation with more than 5,000 circulating lymphoma cells per microliter.
- History or presence of clinically significant CNS pathology.
- CNS involvement from active or history of autoimmune disease.
- Receipt of CD19 CAR T therapy within 3 months prior to first dose.
- Grade 3 or higher cytokine release syndrome after prior T-cell engager or CAR T therapy.
- Grade 2 or higher neurotoxicity or immune effector cell-associated neurotoxicity syndrome after prior T-cell engager or CAR T therapy.
- Peripheral autologous stem cell transplant within 12 weeks or allogeneic transplant within 1 year prior to first dose; ongoing immunosuppressive therapy after transplant.
- HIV infection or chronic/active hepatitis B or C infection, except controlled or cured cases as specified.
- History of major cardiac abnormalities.
- Pregnancy or breastfeeding if female.
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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