Actively Recruiting
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-11-20
132
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with the study protocol
- Adults aged 18 years or older
- Diagnosis of CD20+ B-cell Non-Hodgkin Lymphoma relapsed after or refractory to at least one prior anti-CD20 monoclonal antibody treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Measurable disease with at least one nodal lesion >1.5 cm or extranodal lesion >1.0 cm in longest dimension
- Adequate hematologic, hepatic, and renal function
You will not qualify if you...
- Diagnosis of chronic lymphoblastic leukemia, Burkitt lymphoma, or lymphoplasmacytic lymphoma
- History of central nervous system lymphoma or other CNS disease
- 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 first MBS303 dose
- Active or suspected autoimmune diseases
- Known severe allergic or infusion reaction to monoclonal antibodies
- Significant uncontrolled concomitant disease
- Major surgery within 28 days prior to first MBS303 dose or planned major surgery during study treatment
- History of other invasive malignant tumors within past 3 years
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Severe hemorrhagic diseases requiring transfusion or medical intervention
- Infection with HIV, hepatitis B or C
- Pregnant or lactating women; females of childbearing potential must use two reliable contraception methods or abstain from heterosexual contact during study and for 12 months after study treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yuqin Song, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here