A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
Able and willing to provide written informed consent and to comply with the study protocol;
≥18 years of age;
Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.
Phase Ⅰb/Ⅱ: At least one measurable disease: Serum monoclonal paraprotein (M-protein) ≥5 g/L or Urine M-protein ≥200 mg/24 hours or Serum immunoglobulin free-light chains (FLCs) ≥100 mg/L and abnormal kappa/lambda FLC ratio (<0.26 or >1.65)
Disqualifiers
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Participants with known active infection within 14 days prior to the first MBS314.
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal hepatitis B virus DNA or hepatitis C virus RNA).
Previously received anti-myeloma treatment within the specified time frame prior to the first administration.
Trial design
Treatments tested in this trial
- MBS314 Injection
Treatment groups
154 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov