This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Escalating doses by IV infusion
Dose-limiting toxicities and adverse events
Time frame: Length of study
Pharmacokinetic parameters; CD19-positive B-cell counts
Time frame: Length of study
Overall response; and progression-free survival (Ph. 2 only)
Time frame: Length of study
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