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Recruiting
NCT06526793
Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL
Conditions: B-cell Non-Hodgkin Lymphoma, Follicular Lymphoma (FL), Large B-Cell Lymphoma (LBCL)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 270
Sponsor: AstraZeneca
Location: Research Site Phoenix Arizona
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT06526793). StuddyBuddy aggregates publicly available trial information.