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

Beijing Mabworks Biotech Co., Ltd.1 site in 1 country132 target enrollmentJune 28, 2023

ConditionsNon-Hodgkin's Lymphoma

InterventionsMBS303

DrugsMBS303

Overview

Phase: Phase 1
Intervention: MBS303
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Enrollment: 132
Locations: 1
Primary Endpoint: Phase I：Incidence of Dose Limiting Toxicities (DLTs)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

June 28, 2023

End Date

November 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Mabworks Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•Life expectancy ≥3 months;
•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
•Adequate hematologic, hepatic, and renal function.

Exclusion Criteria

•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;
•Active or suspected autoimmune diseases;
•Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
•Evidence of significant, uncontrolled concomitant disease;
•Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
•History of another invasive malignant tumors in past 3 years;
•Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);

Arms & Interventions

MBS303

Intervention: MBS303

Outcomes

Primary Outcomes

Phase I：Incidence of Dose Limiting Toxicities (DLTs)

Time Frame: From Baseline up to 3 weeks

Phase I：Percentage of Participants with Adverse Events (AEs)

Time Frame: From Baseline up to approximately 13 months

Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0

Phase Ⅱ ：Antitumor activity as measured by the objective response rate (ORR)

Time Frame: Up to approximately 2 years

Phase I：Maximum Tolerated Dose (MTD) of MBS303

Time Frame: From Baseline up to 3 weeks

Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS303

Time Frame: From Baseline up to 4 years

Secondary Outcomes

Phase I and Ⅱ ：Efficacy: Progression-Free Survival (PFS) of MBS303 as Assessed Using Standard Criteria for NHL(Up to approximately 2 years)
Phase I :Efficacy: ORR(Up to approximately 2 years)
Phase I and Ⅱ ：Pharmacokinetics: AUC(up to approximately 1 year)
Phase I and Ⅱ ：Pharmacokinetics: t1/2(up to approximately 1 year)
Phase I and Ⅱ ：Pharmacokinetics: CL(up to approximately 1 year)
Phase I and Ⅱ ：Efficacy: Complete Response Rate (CRR) of MBS303 as Assessed Using Standard Criteria for NHL(Up to approximately 2 years)
Phase I and Ⅱ ：Efficacy: Duration of Response (DOR) of MBS303 as Assessed Using Standard Criteria for NHL(Up to approximately 2 years)
Phase I and Ⅱ ：Pharmacokinetics: Vd(up to approximately 1 year)
Phase I and Ⅱ ：Efficacy: Overall Survival (OS) of MBS303(Up to approximately 2 years)
Phase I and Ⅱ ：Immunogenicity: Anti-Drug Antibodies (ADA) to MBS303(Up to approximately 1 year)