Evaluating MBS314 for patients with relapsed or 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.

This study is testing a new treatment called MBS314 to see if it can help people with relapsed or refractory multiple myeloma feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT06232096 on ClinicalTrials.gov

What this trial studies

This is a Phase I/II, multicenter, open-label study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of MBS314, a novel asymmetric trivalent tri-specific humanized antibody, administered via intravenous infusion. The study is divided into two parts: a dose escalation phase (Phase Ia) and an expansion phase (Phase Ib/II). Participants must have a documented diagnosis of multiple myeloma and meet specific eligibility criteria to be included.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of multiple myeloma and measurable disease.

Not a fit: Patients with active central nervous system involvement or significant infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: While this approach is novel, similar studies targeting multiple myeloma have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol;
2. ≥18 years of age;
3. Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.
4. 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)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
6. Life expectancy ≥3 months.
7. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
2. Participants with known active infection within 14 days prior to the first MBS314.
3. 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).
4. Previously received anti-myeloma treatment within the specified time frame prior to the first administration.
5. Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.
6. Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.
7. Participants with a history of autoimmune diseases.
8. Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.

Where this trial is running

Beijing

• Institute of Hematology and Blood Diseases Hospital — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Lugui Qiu, Doctor — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Lugui Qiu, Doctor

Conditions: Relapsed or Refractory Multiple Myeloma