Actively Recruiting
A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-03-15
154
Participants Needed
1
Research Sites
209 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 asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).
CONDITIONS
Official Title
A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with the study protocol
- 18 years of age or older
- Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria
- For Phase Ib/II: at least one measurable disease marker such as serum monoclonal paraprotein \u22655 g/L, urine M-protein \u2265200 mg/24 hours, or abnormal serum free-light chains with abnormal kappa/lambda ratio
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Life expectancy of at least 3 months
- Adequate blood, liver, and kidney function
You will not qualify if you...
- Known active central nervous system involvement or signs of meningeal involvement of multiple myeloma
- Active infection within 14 days before the first MBS314 dose
- Infection with HIV, hepatitis B, or hepatitis C
- Received anti-myeloma treatment within the specified time before the first dose
- Received live, attenuated vaccines within 28 days before first infusion or expected during the study
- Major surgery within 28 days before first infusion or planned during treatment
- History of autoimmune diseases
- Known severe allergic reactions to other antibodies or to components of MBS314
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lugui Qiu, 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