A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.

Last updated: March 14, 2024
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Multiple Myeloma

Lymphoproliferative Disorders

Treatment

MBS314 Injection

Clinical Study ID

NCT06232096
MBS314-CT101
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Able and willing to provide written informed consent and to comply with the studyprotocol;
  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

Exclusion Criteria:

  1. Known active central nervous system (CNS) involvement or exhibits clinical signs ofmeningeal 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 Cvirus RNA).
  4. Previously received anti-myeloma treatment within the specified time frame prior tothe first administration.
  5. Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, orexpected to receive live, attenuated vaccines during the study period.
  6. Major surgery within 28 days prior to the first infusion of MBS314, or expected toundergo 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 orhypersensitivity to any components of MBS314.

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: MBS314 Injection
Phase: 1/2
Study Start date:
February 22, 2024
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Institute of Hematology and Blood Diseases Hospital

    Beijing,
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.