What this study is
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.
What's being tested
- Surovatamig
Intervention · DRUG
Investigational Product administered via intravenous infusion.
Study details
- Official title
- A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
- Sponsor
- AstraZeneca
- Conditions
- B-cell Non-Hodgkin Lymphoma · Follicular Lymphoma (FL) · Large B-Cell Lymphoma (LBCL)
- Enrolling
- 270 people
- Starts
- 2024-11-27
- Est. completion
- 2032-10-21
- Design
- Open-label, non-randomized, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Aged 18 years old and above
- Histologically confirmed relapsed refractory FL (Module 1) and LBCL (Module 2) after at least 2 prior lines of therapy
- ECOG performance status 0 to 2
- Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy
- FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (defined as > 1.0 cm in its longest dimension)
- Adequate hematological function: ANC ≥ 1000/mm3, platelets; 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
- Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN or < 5 × ULN in the presence of lymphoma involvement of the liver
- Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
- Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA
You can't join if
- Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
- Active CNS involvement by B-NHL
- Leukemic presentation of B-NHL
- History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or other severe mental illness.
- Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig
- Requires chronic immunosuppressive therapy
- Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
- History of major cardiac abnormalities.
- If female, participant must not be pregnant or breastfeeding.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (94)
80 openResearch Site
Duarte, California, United States
RecruitingResearch Site
Tampa, Florida, United States
RecruitingResearch Site
Chicago, Illinois, United States
RecruitingResearch Site
Waukee, Iowa, United States
RecruitingResearch Site
Rochester, Minnesota, United States
RecruitingResearch Site
New York, New York, United States
RecruitingResearch Site
Charlotte, North Carolina, United States
RecruitingResearch Site
Columbus, Ohio, United States
RecruitingResearch Site
Portland, Oregon, United States
RecruitingResearch Site
Philadelphia, Pennsylvania, United States
RecruitingResearch Site
Pittsburgh, Pennsylvania, United States
RecruitingResearch Site
Nashville, Tennessee, United States
RecruitingResearch Site
Austin, Texas, United States
RecruitingResearch Site
Houston, Texas, United States
RecruitingResearch Site
San Antonio, Texas, United States
RecruitingResearch Site
Milwaukee, Wisconsin, United States
RecruitingResearch Site
Phoenix, Arizona, United States
WithdrawnResearch Site
Jacksonville, Florida, United States
WithdrawnResearch Site
Iowa City, Iowa, United States
WithdrawnResearch Site
Overland Park, Kansas, United States
WithdrawnResearch Site
St Louis, Missouri, United States
WithdrawnResearch Site
New Brunswick, New Jersey, United States
WithdrawnResearch Site
Pittsburgh, Pennsylvania, United States
Withdrawn
71 sites outside the US
Research Site
Heidelberg, Australia
RecruitingResearch Site
Kogarah, Australia
RecruitingResearch Site
Macquarie University, Australia
RecruitingResearch Site
Nedlands, Australia
RecruitingResearch Site
Brampton, Ontario, Canada
RecruitingResearch Site
Ottawa, Ontario, Canada
RecruitingResearch Site
Toronto, Ontario, Canada
RecruitingResearch Site
Chengdu, China
RecruitingResearch Site
Chengdu, China
RecruitingResearch Site
Guangzhou, China
RecruitingResearch Site
Nanchang, China
RecruitingResearch Site
Nanjing, China
RecruitingResearch Site
Nantong, China
RecruitingResearch Site
Shandong, China
RecruitingResearch Site
Shanghai, China
RecruitingResearch Site
Shanghai, China
RecruitingResearch Site
Tianjin, China
RecruitingResearch Site
Zhengzhou, China
RecruitingResearch Site
Copenhagen, Denmark
RecruitingResearch Site
Vejle, Denmark
RecruitingResearch Site
Montpellier, France
RecruitingResearch Site
Paris, France
RecruitingResearch Site
Pierre-Bénite, France
RecruitingResearch Site
Rouen, France
RecruitingResearch Site
Berlin, Germany
RecruitingResearch Site
Chemnitz, Germany
RecruitingResearch Site
Essen, Germany
RecruitingResearch Site
Jena, Germany
RecruitingResearch Site
Würzburg, Germany
RecruitingResearch Site
Hong Kong, Hong Kong
RecruitingResearch Site
Shatin, Hong Kong
RecruitingResearch Site
Alessandria, Italy
RecruitingResearch Site
Bologna, Italy
RecruitingResearch Site
Busto Arsizio, Italy
RecruitingResearch Site
Milan, Italy
RecruitingResearch Site
Milan, Italy
RecruitingResearch Site
Chiba, Japan
RecruitingResearch Site
Kashiwa, Japan
RecruitingResearch Site
Kōtoku, Japan
RecruitingResearch Site
Kumamoto, Japan
RecruitingResearch Site
Niigata, Japan
RecruitingResearch Site
Okayama, Japan
RecruitingResearch Site
Osaka, Japan
RecruitingResearch Site
Yokohama, Japan
RecruitingResearch Site
Seoul, South Korea
RecruitingResearch Site
Seoul, South Korea
RecruitingResearch Site
Seoul, South Korea
RecruitingResearch Site
Seoul, South Korea
RecruitingResearch Site
Seoul, South Korea
RecruitingResearch Site
Barcelona, Spain
RecruitingResearch Site
Madrid, Spain
RecruitingResearch Site
Pozuelo de Alarcón, Spain
RecruitingResearch Site
Gothenburg, Sweden
RecruitingResearch Site
Stockholm, Sweden
RecruitingResearch Site
Kaohsiung City, Taiwan
RecruitingResearch Site
Taichung, Taiwan
RecruitingResearch Site
Taichung, Taiwan
RecruitingResearch Site
Tainan, Taiwan
RecruitingResearch Site
Taipei, Taiwan
RecruitingResearch Site
London, United Kingdom
RecruitingResearch Site
Manchester, United Kingdom
RecruitingResearch Site
Norwich, United Kingdom
RecruitingResearch Site
Nottingham, United Kingdom
RecruitingResearch Site
Plymouth, United Kingdom
RecruitingResearch Site
Porto Alegre, Brazil
WithdrawnResearch Site
São Paulo, Brazil
Active, not recruitingResearch Site
São Paulo, Brazil
Active, not recruitingResearch Site
Barrie, Ontario, Canada
WithdrawnResearch Site
Aalborg, Denmark
WithdrawnResearch Site
Roma, Italy
WithdrawnResearch Site
Kaohsiung City, Taiwan
Withdrawn
Study team
Sponsor
AstraZeneca
Study ID D7404C00001
CONTACT
AstraZeneca Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.