NCT06232096RecruitingPhase 1/2
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 · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 22 Jan 2024
- Start date
- 22 Feb 2024
- Primary completion date
- Feb 2026
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT06232096
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 154
- From 22 Feb 2024 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.