A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MBS314 Injection
DrugPhase 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.
Treatment groups
154 Participants
are divided into 1 treatment groupGroup A: MBS314Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase Ia:Percentage of Participants with Adverse Events (AEs) .
Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
Time frame
From Baseline up to approximately 29 months2
Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
DLTs:Incidence of Dose Limiting Toxicities
Time frame
From Baseline up to 4 weeks3
Phase Ia:Maximum Tolerated Dose (MTD) of MBS314
MTD:Maximum Tolerated Dose
Time frame
Up to approximately 11 months4
Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314
RP2D: Recommended Phase II Dose
Time frame
Up to approximately 29 monthsSecondary outcomes
1
Efficacy: Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to the IMWG response criteria.
Time frame
Up to approximately 4 year2
Efficacy: Complete Response (CR) or Better Rate
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.
Time frame
Up to approximately 4 year3
Efficacy: Minimal Residual Disease (MRD) Negative Rate
Minimal Residual Disease (MRD) Negative Rate
Time frame
Up to approximately 4 years4
Efficacy: Very Good Partial Response (VGPR) or Better Rate
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to the IMWG response criteria.
Time frame
Up to approximately 4 yearSponsors and contacts
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Source ClinicalTrials.gov