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Phase 1/2Recruiting

A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Sponsor
BioInvent International AB (Industry)
Enrollment
140 planned
Conditions
Indolent B-Cell Non-Hodgkin Lymphoma
Interventions
BI-1206; Rituximab; Acalabrutinib
Ages
adults, older adults
Registry
NCT03571568

Full record on ClinicalTrials.gov

From the registry

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Primary outcomes

  • Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib
  • Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT)
  • Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib

History

  1. Primary completion expected

  2. Last registry update

  3. Registered

  4. Started