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NCT Number: NCT06232096

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

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  • Participants with known active infection within 14 days prior to the first MBS314.
  • 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).
  • 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.
  • Participants with a history of autoimmune diseases.
  • Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.

Treatment and study plan

MBS314 Injection

Drug

Phase Ia: The patients confirming to the eligibility criteria will be assigned to 1 of the 7 dose groups (0.03/0.09/0.3/0.9 mg ~ 0.3/1.5/9.0/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS314 as per the schedule specified in the respective arms.

Phase Ib/Ⅱ: Based on the results of Phase Ⅰa, 1 or 2 recommended doses will be selected for Phase Ⅰb. Recommended Phase II Dose (RP2D) will be selected for Phase Ⅱ.

Primary outcomes

  1. Phase Ia:Percentage of Participants with Adverse Events (AEs) .

    Time frame: From Baseline up to approximately 29 months

    Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.

  2. Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)

    Time frame: From Baseline up to 4 weeks

    DLTs:Incidence of Dose Limiting Toxicities

  3. Phase Ia:Maximum Tolerated Dose (MTD) of MBS314

    Time frame: Up to approximately 11 months

    MTD:Maximum Tolerated Dose

  4. Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314

    Time frame: Up to approximately 29 months

    RP2D: Recommended Phase II Dose

  5. Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)

    Time frame: Up to approximately 4 years

    ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) response criteria assessed by the IRC.

Secondary outcomes

  1. Efficacy: Stringent Complete Response (sCR) Rate

    Time frame: Up to approximately 4 year

    sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to the IMWG response criteria.

  2. Efficacy: Complete Response (CR) or Better Rate

    Time frame: Up to approximately 4 year

    CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to the IMWG response criteria.

  3. Efficacy: Minimal Residual Disease (MRD) Negative Rate

    Time frame: Up to approximately 4 years

    Minimal Residual Disease (MRD) Negative Rate

  4. Efficacy: Very Good Partial Response (VGPR) or Better Rate

    Time frame: Up to approximately 4 year

    VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to the IMWG response criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Lugui Qiu, Doctor

CONTACT

[email protected]

0086-022-23608560

Sponsors and collaborators

Lead sponsor

Beijing Mabworks Biotech Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 30, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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