Surovatamig: Investigational Product administered via intravenous infusion.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1. Key Inclusion Criteria:
* 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
The above is a summary, other inclusion criteria details may apply.
2. Key Exclusion Criteria:
* 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.
The above is a summary, other exclusion criteria details may apply.
Primary outcome measure(s)
Overall response rate (ORR) (central review) — Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months. Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a Partial Response (PR) or Complete Response (CR) based on Lugano 2014 response criteria for non-Hodgkin Lymphoma, as determined by central review
Trial sites (94)
Facility
City
Region
Status
Research Site
Phoenix
Arizona
Withdrawn
Research Site
Duarte
California
Recruiting
Research Site
Jacksonville
Florida
Withdrawn
Research Site
Tampa
Florida
Recruiting
Research Site
Chicago
Illinois
Recruiting
Research Site
Iowa City
Iowa
Withdrawn
Research Site
Waukee
Iowa
Recruiting
Research Site
Overland Park
Kansas
Withdrawn
Research Site
Rochester
Minnesota
Recruiting
Research Site
St Louis
Missouri
Withdrawn
Research Site
New Brunswick
New Jersey
Withdrawn
Research Site
New York
New York
Recruiting
Research Site
Charlotte
North Carolina
Recruiting
Research Site
Columbus
Ohio
Recruiting
Research Site
Portland
Oregon
Recruiting
Research Site
Philadelphia
Pennsylvania
Recruiting
Research Site
Pittsburgh
Pennsylvania
Recruiting
Research Site
Pittsburgh
Pennsylvania
Withdrawn
Research Site
Nashville
Tennessee
Recruiting
Research Site
Austin
Texas
Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
San Antonio
Texas
Not Yet Recruiting
Research Site
Milwaukee
Wisconsin
Recruiting
Research Site
Heidelberg
Australia
Recruiting
Research Site
Kogarah
Australia
Recruiting
Research Site
Macquarie University
Australia
Recruiting
Research Site
Nedlands
Australia
Recruiting
Research Site
Porto Alegre
Brazil
Withdrawn
Research Site
São Paulo
Brazil
Active Not Recruiting
Research Site
São Paulo
Brazil
Active Not Recruiting
Research Site
Barrie
Ontario
Withdrawn
Research Site
Brampton
Ontario
Recruiting
Research Site
Ottawa
Ontario
Recruiting
Research Site
Toronto
Ontario
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Nanchang
China
Recruiting
Research Site
Nanjing
China
Recruiting
Research Site
Nantong
China
Recruiting
+ 54 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.