Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase 1a/1b Study of PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies
Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells. Study: Multi-center-, International Phase 1a/1b (Escalation/Expansion) study in patients with indolent-, relapsed-, B-cell malignancies. The Phase 1a (Dose Escalation) part of study follows a 3+3 design.
Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells. Study: Multi-center-, International Phase 1a/1b (Escalation/Expansion) study in patients with indolent-, relapsed-, CD20+ and CD37+ expressing B-cell malignancies. Phase 1a (Dose Escalation) portion of study follows 3+3 design. Phase 1b (Expansion) enrolls with up to 20 patients in each one of 3 disease-specific cohorts: (1) FL; (2) CLL/SLL, and (3) a mixed indolent B-cell histology cohort comprising WM, indolent phenotype MCL, and MZL. Primary objectives for Phase 1a are Safety (DLT) and establishing a recommended Phase 1b dose. Primary objective for Phase 1b is establishing preliminary evidence of an anti-lymphoma response in each of the 3 Expansion cohorts, as determined by ORR. ;
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