A Phase Ib, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Efficacy Of Subcutaneous Glofitamab Following Obinutuzumab Pretreatment in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.
Primary Objective:
To evaluate the safety and tolerability of glofitamab SC administration.
Secondary:
1. To characterize the PK profile of glofitamab SC administration.
2. To evaluate the preliminary efficacy of glofitamab given subcutaneously followed
by IV and/or SC administration.
3. To evaluate potential effects of ADAs.
4. To evaluate the relationship between glofitamab exposure and pharmacodynamic biomarkers.
5. To evaluate the preliminary efficacy of tocilizumab in ameliorating the symptoms of
severe CRS following glofitamab treatment.
Glofitamab
Tocilizumab
- Rutgers University
Inclusion Criteria: - History or status of a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; relapse after or failure to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival (Part I and II); relapsed after or failed to respond to only one prior systemic treatment regimen (Part III) - Must have at least one measurable target lesion (>/= 1.5 cm) in its largest dimension by computed tomography scan - Able and willing to provide a fresh biopsy from a safely accessible site, per Investigator's determination, providing the participant has more than one measurable target lesion - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or /= 12 weeks - Adverse events from prior anti-cancer therapy must have resolved to Grade
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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