Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06564038

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

Led by AstraZeneca · Updated on 2026-05-14

408

Participants Needed

64

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

CONDITIONS

Official Title

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 last dose
  • Confirmed CD19 expression if previously treated with anti-CD19 therapy
  • For CLL: requires treatment based on iwCLL criteria
  • For SLL: at least one measurable site
  • Absolute lymphocyte count less than 25000 cells/mcL
  • For Cohorts 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL
  • For Cohort 1B: at least 1 prior therapy line and sensitivity to Bruton tyrosine kinase inhibitors
  • For MCL: diagnosis per WHO criteria
  • Clinical Stage II, III, or IV by Ann Arbor Classification
  • At least one measurable site
  • For Cohorts 2A and 2C: relapse or progression after 2 or more therapy lines including BTKi
  • For LBCL and R/R B-NHL: at least one measurable site
  • Left ventricular ejection fraction at least 50%
  • Age 79 years or younger at consent
  • Use of contraception for required periods after last doses
  • For Cohort 3A: histologically confirmed untreated LBCL and R/R B-NHL with at least 1 prior therapy and IPI 2-5
  • For Cohort 3B: histologically confirmed untreated LBCL and IPI score 2 to 5
Not Eligible

You will not qualify if you...

  • Central nervous system lymphoma
  • Surgery within 14 days before study drug
  • Clinically significant cardiovascular disease
  • Unresolved Grade greater than 2 adverse events from prior therapy (except hair loss or fatigue)
  • Systemic therapy within 5 half-lives or 21 days before treatment
  • Radiation therapy within 28 days
  • 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 neurotoxicity
  • Prior allogeneic stem cell transplant or solid organ transplant within 24 weeks before treatment
  • Active uncontrolled infection or autoimmune disease needing systemic therapy
  • History of hemophagocytic lymphohistiocytosis
  • For Substudy 1 Cohort 1B: bleeding disorders, CYP3A inhibitors or inducers, recent intracranial hemorrhage or stroke, gastrointestinal malabsorption, or use of vitamin K antagonists
  • CLL/SLL transformed to aggressive lymphoma
  • For Substudy 3: mediastinal grey-zone lymphoma, Burkitt lymphoma, Richter's transformation, primary effusion large B-cell lymphoma
  • Cumulative anthracycline dose greater than 150 mg/m2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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

7

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A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies | DecenTrialz