RECRUITING

Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-11-27
Study Completion:2029-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06526793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years old and above
  2. * Histologically confirmed relapsed refractory FL (Module 1) and LBCL (Module 2) after at least 2 prior lines of therapy
  3. * ECOG performance status 0 to 2
  4. * Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy
  5. * 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)
  6. * Adequate hematological function: ANC ≥ 1000/mm3, platelets
  7. * 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
  8. * Adequate liver function: total bilirubin \<1.5x ULN, AST/ALT ≤ 3xULN or \< 5 × ULN in the presence of lymphoma involvement of the liver
  9. * Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
  10. * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA
  11. 2. Key
  1. * Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
  2. * Active CNS involvement by B-NHL
  3. * Leukemic presentation of B-NHL
  4. * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis or other severe mental illness
  5. * 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
  6. * Requires chronic immunosuppressive therapy
  7. * Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
  8. * History of major cardiac abnormalities.
  9. * If female, participant must not be pregnant or breastfeeding.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Duarte, California, 91010
United States
Research Site
Tampa, Florida, 33612
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Waukee, Iowa, 50263
United States
Research Site
Overland Park, Kansas, 66204
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
St Louis, Missouri, 63110
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
New York, New York, 10016
United States
Research Site
Charlotte, North Carolina, 28204
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Pittsburgh, Pennsylvania, 15232
United States
Research Site
Pittsburgh, Pennsylvania, 15232
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Austin, Texas, 78704
United States
Research Site
Houston, Texas, 77030
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-27
Study Completion Date2029-06-14

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2029-06-14

Terms related to this study

Keywords Provided by Researchers

  • AZD0486
  • Surovatamig
  • Follicular Lymphoma (FL)
  • Large B-Cell Lymphoma (LBCL)
  • Non-Hodgkin lymphoma (NHL)
  • Relapsed/Refractory

Additional Relevant MeSH Terms

  • B-cell Non-Hodgkin Lymphoma
  • Follicular Lymphoma (FL)
  • Large B-Cell Lymphoma (LBCL)