RecruitingPhase 1Phase 2NCT05806099

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

A Phase I/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Sponsor

Beijing Mabworks Biotech Co., Ltd.

Enrollment

132 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin's Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing the safety, dosing, and early effectiveness of a new drug called MBS303 for people with a type of blood cancer called B-cell Non-Hodgkin Lymphoma (NHL) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with CD20-positive B-cell Non-Hodgkin Lymphoma - Your cancer has relapsed or did not respond to at least one prior treatment that included an anti-CD20 antibody (like rituximab) - You are in generally good physical shape (able to perform self-care) - You have a life expectancy of at least 3 months - You have at least one measurable area of disease **You may NOT be eligible if...** - You have not previously tried an anti-CD20 therapy - You are in poor overall health - You have very limited life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMBS303

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

Locations(1)

Beijing Cancer Hospital

Beijing, China

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NCT05806099

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