Actively Recruiting
A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Led by AstraZeneca · Updated on 2026-05-08
91
Participants Needed
22
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
CONDITIONS
Official Title
A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Documented diagnosis of B-cell Non-Hodgkin Lymphoma according to WHO 2021 classification
- For dose escalation phase, any B-NHL subtype allowed except some exclusions; for backfill phase, only specific subtypes: large B-cell lymphomas, mantle cell lymphoma, and follicular lymphoma grades 1-3a
- Relapsed or refractory disease after at least two prior therapies with no standard options offering survival benefit
- Large B-cell lymphoma patients must have progressed after anti-CD20 and at least one chemotherapy and be considered or ineligible for CAR-T, T cell engager, or stem cell transplant
- Mantle cell lymphoma patients must have received anti-CD20 and Bruton's Tyrosine Kinase inhibitor
- Follicular lymphoma patients must have failed anti-CD20 and have active disease requiring therapy
- Measurable disease by Lugano 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate organ and bone marrow function as defined by specified laboratory and clinical parameters
You will not qualify if you...
- Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Active central nervous system involvement from B-NHL
- Receipt of CAR-T or T cell engager therapy within 90 days before Cycle 1 Day 1
- Use of investigational drug or other systemic anticancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives of study start
- Curative radiation therapy within 14 days before study start (localized palliative radiation allowed)
- Allogeneic hematopoietic stem cell transplant within 180 days unless stable without active graft-versus-host disease for at least 2 months
- Autologous hematopoietic stem cell transplant within 90 days unless toxicities resolved
- Major surgery within 28 days before study start
- Use of strong CYP3A4 inhibitors or QT interval-prolonging agents at study start
- Other malignancies within 2 years
- Unresolved grade 2 or higher adverse events from prior therapy (except certain tolerable conditions)
- Serious uncontrolled medical conditions
- Active infection within 14 days before study start
- History or suspicion of significant interstitial lung disease or pneumonitis
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Research Site
Irvine, California, United States, 92618
Actively Recruiting
2
Research Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Research Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Research Site
New York, New York, United States, 10016
Actively Recruiting
5
Research Site
New York, New York, United States, 10021
Actively Recruiting
6
Research Site
Cleveland, Ohio, United States, 44195
Withdrawn
7
Research Site
Myrtle Beach, South Carolina, United States, 29572
Withdrawn
8
Research Site
Franklin, Tennessee, United States, 37067
Actively Recruiting
9
Research Site
Melbourne, Australia, 3000
Actively Recruiting
10
Research Site
Chengdu, China, 610041
Not Yet Recruiting
11
Research Site
Guangzhou, China, 510060
Not Yet Recruiting
12
Research Site
Bologna, Italy, 40138
Actively Recruiting
13
Research Site
Milan, Italy, 20133
Actively Recruiting
14
Research Site
Milan, Italy, 20141
Actively Recruiting
15
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
16
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
17
Research Site
Seoul, South Korea, 03080
Actively Recruiting
18
Research Site
Seoul, South Korea, 5505
Actively Recruiting
19
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
20
Research Site
Taipei, Taiwan, 106
Actively Recruiting
21
Research Site
London, United Kingdom, W1T 7HA
Actively Recruiting
22
Research Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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