Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBS314 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MBS314
- interventionNames
- Drug: MBS314 Injection
Primary outcomes (5)
- measure
- Phase Ia:Percentage of Participants with Adverse Events (AEs) .
- timeFrame
- From Baseline up to approximately 29 months
- description
- Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
- measure
- Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
- timeFrame
- From Baseline up to 4 weeks
- description
- DLTs:Incidence of Dose Limiting Toxicities
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available