A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
Trial Parameters
Brief Summary
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol. 2. Adult patients, ≥18 years of age; 3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve survival; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. Life expectancy ≥3 months; 6. Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \>1.0 cm in its longest dimension 7. Adequate hematologic, hepatic, and renal function. Exclusion Criteria: 1. Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom; 2. History of central nervous system (CNS) lymphoma or other CNS disease; 3. Participants with known active in