NCT06232096 A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
| NCT ID | NCT06232096 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Mabworks Biotech Co., Ltd. |
| Condition | Relapsed or Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 154 participants in total. It began in 2024-02-22 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Lugui Qiu, Doctor
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT06232096 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06232096 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06232096 currently recruiting?
Yes, NCT06232096 is actively recruiting participants. Contact the research team at Qiulg@ihcams.ac.cn for enrollment information.
Where is the NCT06232096 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06232096 clinical trial?
NCT06232096 is sponsored by Beijing Mabworks Biotech Co., Ltd.. The principal investigator is Lugui Qiu, Doctor at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 154 participants.