Tests MBS314 in adults with relapsed or refractory multiple myeloma
Tests the new antibody MBS314 in adults with returning or resistant myeloma.
Plain-language title generated from the registry record
Registry title: A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Institute of Hematology and Blood Diseases HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Mabworks Biotech Co., Ltd.
- Trial code
- NCT06232096
- Record updated
- 15 March 2024
- Original description
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).Read full original descriptionShow less
A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
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).
Inclusion: 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); Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; Life expectancy ≥3 months; Adequate hematologic, hepatic, and renal function.
Exclusion: Participants with known active infection within 14 days prior to the first MBS314; Previously received anti-myeloma treatment within the specified time frame prior to the first administration; Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period; Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment; 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); Participants with a history of autoimmune diseases; Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314; Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.