Actively Recruiting
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
Led by AstraZeneca · Updated on 2026-05-14
408
Participants Needed
64
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of surovatamig, given alone or with other cancer treatments, in people with mature B-cell blood cancers. The study includes participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle-cell lymphoma (MCL), large B-cell lymphoma (LBCL), or other B-cell non-Hodgkin lymphomas. This is an open-label, multi-center study organized into three substudies focusing on different patient groups. Participants receive surovatamig either as a subcutaneous injection or intravenous infusion. Some groups get surovatamig alone, while others receive it combined with other agents such as acalabrutinib tablets or chemotherapy drugs including rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Different dosing schedules are used, including step-up dosing when combined with chemotherapy. The study has a screening period of 28 days, followed by treatment and then a follow-up period. During the study, participants will be closely monitored through assessments of adverse events, dose-limiting toxicities, and response rates over several years. Pharmacokinetic measures like drug concentration and clearance will also be tracked. Researchers will evaluate overall response, complete response, and duration of response. Safety and effectiveness data will be collected up to over six years, with detailed monitoring during and after treatment to understand both short- and long-term effects.
CONDITIONS
Brief Title
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Use of contraception during treatment and for at least 90 days after the final dose
- Confirmed CD19 expression if the participant had prior anti-CD19 therapy
- For chronic lymphocytic leukemia (CLL), treatment required per iwCLL criteria
- Small lymphocytic lymphoma (SLL) with at least 1 measurable site per Lugano
- Absolute lymphocyte count less than 25000 cells/mcL
- At least 2 prior lines of systemic therapy for CLL/SLL for Cohorts 1A and 1C
- At least 1 prior line of therapy and Bruton tyrosine kinase inhibitor (BTKi) sensitivity for Cohort 1B
- Mantle-cell lymphoma diagnosis per WHO
- Clinical Stage II, III, or IV by Ann Arbor Classification
- At least 1 measurable site per Lugano for MCL
- Relapsed or progressed after 2 or more lines of therapy including BTKi for Cohorts 2A and 2C
- At least 1 measurable site per Lugano for large B-cell lymphoma (LBCL)
- Left ventricular ejection fraction equal or above 50%
- No older than 79 years at informed consent
- Contraception for specified periods after last doses of study drugs
- Histologically confirmed diagnosis of previously untreated LBCL per WHO 2022 for Cohorts 3A and 3B
- International Prognostic Index (IPI) score 2 to 5 for Cohorts 3A and 3B
- Relapsed/refractory B-cell non-Hodgkin lymphoma after at least 1 prior systemic therapy for Cohort 3A
You will not qualify if you...
- Central nervous system lymphoma
- Surgery within 14 days prior to study drug
- Clinically significant cardiovascular disease
- Unresolved Grade greater than 2 adverse events from prior anticancer therapy except alopecia or fatigue
- Any systemic therapy within 5 half-lives or 21 days before treatment
- Radiation therapy within 28 days prior to treatment
- Prior CAR T-cell therapy or autologous stem cell transplant within 12 weeks
- Prior T-cell engager therapy within 8 weeks
- Prior Grade greater than 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome
- Prior allogeneic stem cell transplant or solid organ transplant within 24 weeks
- Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy
- Transformation of CLL/SLL to more aggressive lymphoma
- For Cohort 1B: bleeding disorders, use of CYP3A inhibitors or inducers, recent intracranial hemorrhage or stroke within 24 weeks, gastrointestinal malabsorption, or receiving vitamin K antagonist
- Mediastinal grey-zone lymphoma, Burkitt lymphoma, Richter's transformation, or primary effusion large B-cell lymphoma
- Cumulative anthracycline dose over 150 mg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration as per treatment cycles until discontinuation
Participants receive surovatamig either as monotherapy or in combination with other anticancer agents, administered via subcutaneous injection or intravenous infusion, along with standard chemotherapy where applicable.
Multiple visits for dosing and assessments as per treatment schedule
Duration - Up to 6 years and 4 months
Participants are monitored for safety and treatment response after completing treatment.
Visits scheduled for long-term safety and efficacy assessments
Trial Site Locations
Total: 64 locations
1
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Research Site
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
3
Research Site
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
4
Research Site
New York, New York, United States, 10029
Actively Recruiting
5
Research Site
New York, New York, United States, 10065
Withdrawn
6
Research Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
7
Research Site
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
8
Research Site
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Research Site
Portland, Oregon, United States, 97239
Actively Recruiting
10
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
13
Research Site
Houston, Texas, United States, 77030
Not Yet Recruiting
14
Research Site
Heidelberg, Australia, 3084
Actively Recruiting
15
Research Site
Melbourne, Australia, 3004
Actively Recruiting
16
Research Site
Nedlands, Australia, 6009
Actively Recruiting
17
Research Site
Beijing, China, 100044
Actively Recruiting
18
Research Site
Guangzhou, China, 510060
Actively Recruiting
19
Research Site
Jinan, China, 250013
Withdrawn
20
Research Site
Tianjin, China, 300060
Actively Recruiting
21
Research Site
Zhengzhou, China, 450008
Actively Recruiting
22
Research Site
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
23
Research Site
Prague, Czechia, 12808
Actively Recruiting
24
Research Site
Praha 2 - Nové Město, Czechia, 12820
Actively Recruiting
25
Research Site
Aalborg, Denmark, 9000
Actively Recruiting
26
Research Site
Aarhus N, Denmark, 8200
Actively Recruiting
27
Research Site
Copenhagen, Denmark, 2100
Actively Recruiting
28
Research Site
Odense C, Denmark, 5000
Actively Recruiting
29
Research Site
Clermont-Ferrand, France, 63000
Not Yet Recruiting
30
Research Site
Montpellier, France, 34295
Actively Recruiting
31
Research Site
Paris, France, 75010
Actively Recruiting
32
Research Site
Saint-Cloud, France, 92210
Actively Recruiting
33
Research Site
Villejuif, France, 94805
Actively Recruiting
34
Research Site
Cologne, Germany, 50937
Not Yet Recruiting
35
Research Site
Homburg, Germany, 66421
Not Yet Recruiting
36
Research Site
Kiel, Germany, 24105
Actively Recruiting
37
Research Site
Mainz, Germany, 55131
Not Yet Recruiting
38
Research Site
München, Germany, 81377
Actively Recruiting
39
Research Site
Würzburg, Germany, 97080
Actively Recruiting
40
Research Site
Bologna, Italy, 40138
Not Yet Recruiting
41
Research Site
Milan, Italy, 20141
Not Yet Recruiting
42
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
43
Research Site
Matsuyama, Japan, 791-0280
Actively Recruiting
44
Research Site
Nagoya, Japan, 464-8681
Actively Recruiting
45
Research Site
Busan, South Korea, 48108
Actively Recruiting
46
Research Site
Seoul, South Korea, 02841
Actively Recruiting
47
Research Site
Seoul, South Korea, 03080
Actively Recruiting
48
Research Site
Seoul, South Korea, 05505
Actively Recruiting
49
Research Site
Seoul, South Korea, 06351
Actively Recruiting
50
Research Site
Seoul, South Korea, 06591
Actively Recruiting
51
Research Site
Barcelona, Spain, 8036
Actively Recruiting
52
Research Site
Madrid, Spain, 28034
Actively Recruiting
53
Research Site
Madrid, Spain, 28040
Actively Recruiting
54
Research Site
Palma de Mallorca, Spain, 7120
Actively Recruiting
55
Research Site
Santiago de Compostela, Spain, 15706
Actively Recruiting
56
Research Site
Valencia, Spain, 46026
Actively Recruiting
57
Research Site
Changhua, Taiwan, 500
Actively Recruiting
58
Research Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
59
Research Site
Tainan, Taiwan, 710
Actively Recruiting
60
Research Site
Taipei, Taiwan, 100
Actively Recruiting
61
Research Site
Derriford, United Kingdom, PL6 5FP
Actively Recruiting
62
Research Site
London, United Kingdom, SE5 9RS
Actively Recruiting
63
Research Site
Oxford, United Kingdom, 0X3 7LJ
Actively Recruiting
64
Research Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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