A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: I/II (Cancer Control)
Principal Investigator: Vose, Julie
Eligibility: https://clinicaltrials.gov/study/NCT03625037?term=NCT03625037&rank=1
Summary
Expansion Part Only
Primary
To evaluate clinical efficacy as determined by Lugano criteria
Secondary
To further evaluate clinical efficacy as determined by Lugano criteria
To evaluate anti-lymphoma activity as determined by Lymphoma Response to
Immunomodulatory Therapy Criteria (LYRIC)
To further evaluate clinical efficacy
To evaluate MRD status as a clinical efficacy endpoint
To evaluate safety and tolerability of GEN3013
To evaluate the PK and immunogenicity of GEN3013
To evaluate patient-reported outcomes (PROs) related to lymphoma symptoms
Exploratory
To evaluate biomarkers predictive of clinical response to GEN3013
To evaluate pharmacodynamic markers linked to the mechanism of action of GEN3013
To evaluate PROs related to well-being and general health status