Phase I FIH study includes subjects with relapsed/refractory CD20 + non-Hodgkin’s lymphoma, who may benefit from treatment with CHO-H01. In Phase I of the study, the first 2 cohorts will follow a 2-step modified accelerated titration dose escalation design and subsequent cohorts will follow a standard 3+3 dose escalation design.
The investigational medicinal product, CHO-H01, will be administered via IV infusion once weekly for 4 weeks in Cycle 1 and then once only (on Day 1) in each subsequent 21-day cycle until disease progression or for up to 6 cycles (19 weeks) of treatment.
Once the MTD/RP2D has been confirmed, Phase IIa of the study will be initiated. The purpose of Phase IIa is to assess anticancer activity and safety in 2 cohorts of subjects with either aggressive B-cell lymphoma (DLBCL-NOS) or indolent (follicular) B-cell lymphoma, until intolerable toxicity or disease progression, withdrawal, or death occurs.
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