Actively Recruiting
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
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-11-20
132
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a novel T-Cell bispecific drug called MBS303 in adults with relapsed or refractory CD20-positive B-cell Non-Hodgkin Lymphoma (NHL) who have not responded to prior anti-CD20 monoclonal antibody treatment. This Phase I/II multicenter, open-label study aims to evaluate the safety, tolerability, how the drug moves and acts in the body (pharmacokinetics and pharmacodynamics), and its effectiveness against the disease. The study is sponsored by Beijing Mabworks Biotech Co., Ltd. and includes two main parts: dose escalation (Phase I) and dose expansion (Phase II).
CONDITIONS
Brief 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
- Diagnosed with CD20-positive B-cell Non-Hodgkin Lymphoma relapsed or refractory after 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
- Adequate blood, liver, and kidney 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
- Active infections including bacterial, viral, parasitic, or mycobacterial (excluding nail bed fungal infections)
- Surgery, chemotherapy, targeted therapy, immunotherapy, radiation, tumor embolization, or other antitumor therapy within 28 days before first MBS303 dose
- Active or suspected autoimmune diseases
- Known severe allergic or infusion reactions to monoclonal antibodies
- Significant uncontrolled diseases
- Major surgery within 28 days prior to first MBS303 dose or planned during study
- History of other invasive cancers within past 3 years
- History of progressive multifocal leukoencephalopathy (PML)
- Severe bleeding disorders requiring transfusion or medical intervention
- Infection with HIV, hepatitis B or C with abnormal viral markers
- Pregnant or breastfeeding women; females of childbearing potential must use two reliable contraception methods or abstain during study and for 12 months after treatment cessation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 17 cycles of 21 days each (approximately 12 months)
Participants receive MBS303 drug treatment with dose escalation in Phase I and step-up doses followed by target doses in Phase II. Some participants may receive a single IV infusion pretreatment with MIL62 based on safety assessments.
Multiple visits per cycle including dosing on Day 1 and Day 8 of Cycle 1 and Day 1 of subsequent cycles
Duration - Up to approximately 1 year after treatment
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and efficacy outcomes after treatment ends.
Periodic visits scheduled during follow-up
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yuqin Song, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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