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)
Able and willing to provide written informed consent and to comply with the study protocol.
Adult patients, ≥18 years of age;
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;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
History of central nervous system (CNS) lymphoma or other CNS disease;
Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
Single group
MBS303
DrugPhase I: The patients confirming to the eligibility criteria will be assigned to one of the 7 dose groups (0.05/0.15/0.45 mg \~ 1.5/6/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS303 as per the schedule specified in the respective arms. Based on the safety data of the previous dose groups, if pretreatment with MIL62 is required after disussion by the sponsor and the investigators, the subject should be given an IV infusion of MIL62 1000 mg single dose on the D-7. Phase Ⅱ: One or two recommended doses will be selected based on the results of Phase I. Each patient will receive one of the two recommended doses MBS303 as step-up doses on D1 (low dose) and D8 (intermediate dose) of C1 and at the target dose on D1 of C2-17 (21-day cycles). Based on the previous safety data, if pretreatment with MIL62 is required after disussion by the sponsor and the investigators, the subjects should be given an IV infusion of MIL62 1000 mg single dose on the D-7
Phase I：Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0
Phase I：Incidence of Dose Limiting Toxicities (DLTs)
Phase I：Maximum Tolerated Dose (MTD) of MBS303
Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS303
Phase I and Ⅱ ：Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of MBS303 after the administration
Phase I and Ⅱ ：Pharmacokinetics: t1/2
Half-life (t1/2) of MBS303 after administration
Phase I and Ⅱ ：Pharmacokinetics: CL
Clearance (CL) of MBS303 after administration
Phase I and Ⅱ ：Pharmacokinetics: Vd
Volume of distribution (Vd) of MBS303 after administration
Click on the lead sponsor to view all of their trials.
