A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
Beijing Mabworks Biotech Co., Ltd.
154 participants
Feb 22, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 Criteria8
- 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.
- 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.
- Participants with a history of autoimmune diseases.
- Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.
Interventions
Phase Ia: The patients confirming to the eligibility criteria will be assigned to 1 of the 7 dose groups (0.03/0.09/0.3/0.9 mg \~ 0.3/1.5/9.0/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS314 as per the schedule specified in the respective arms. Phase Ib/Ⅱ: Based on the results of Phase Ⅰa, 1 or 2 recommended doses will be selected for Phase Ⅰb. Recommended Phase II Dose (RP2D) will be selected for Phase Ⅱ.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06232096