A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Lymphoma of B-cell origin

Escalation End Points: - Dose limiting toxicity - Adverse events, Expansion End Points: - Overall response rate (ORR) determined by Lugano criteria as assessed by independent review committee (IRC), Optimization End Points: - Adverse events; Rating of ≥ Grade 2 CRS events

Escalation End Points: - Cytokine measures - Laboratory parameters (biochemistry, hematology including immunophenotyping for absolute T-cell and B-cell counts as well as Tcell activation and exhaustion markers) - PK parameters (clearance, volume of distribution and area-under-the concentration- time curve (AUC0-Clast and AUC0-∞), maximum concentration (Cmax), time of Cmax (Tmax), pre dose values, and halflife), Escalation End Points: - Immunogenicity of GEN3013 - Anti-lymphoma activity, i.e. resolution of constitutional symptoms, reduction in tumor size, objective and best response - Duration of response - Progression free survival - Time to next anti-lymphoma therapy - Overall survival, Expansion Efficacy End Points per IRC and Optimization Efficacy End Points per Investigator: - Duration of response (DOR) determined by Lugano criteria - Complete response (CR) rate determined by Lugano criteria - Duration of CR (DoCR) by Lugano criteria - Progression-free survival (PFS) determined by Lugano criteria - Time to response (TTR) determined by Lugano criteria, Expansion Efficacy End Points per IRC and Optimization Efficacy End Points per Investigator: - Objective and best response rate determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) - PFS determined by LYRIC - DOR determined by LYRIC - DoCR determined by LYRIC - TTR determined by LYRIC - Overall survival (OS), Expansion Efficacy End Points per IRC and Optimization Efficacy End Points per Investigator: - Time to next (anti-lymphoma) therapy (TTNT) - Rate of MRD negativity - Safety (i.e., adverse events, laboratory parameters, hospitalizations, and cytokine measures), Expansion Efficacy End Points per IRC and Optimization Efficacy End Points per Investigator: - PK parameters (clearance, volume of distribution, Cmax, Tmax, trough concentrations, and half-life) and incidence of ADAs to GEN3013 - Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym), Expansion Efficacy End Points per IRC and Optimization Efficacy End Points per Investigator: - Rate of ≥ Grade 2 CRS events and all grade CRS events following first full dose Rate of ≥ Grade 2 CRS events and all grade CRS events overall

No related papers found yet.

Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden