A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

June 28, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

MBS303

"Phase 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"

Trial Locations (1)

Unknown

RECRUITING

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY