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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
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.
Institute of Hematology and Blood Diseases Hospital
Beijing, China
RECRUITINGPhase 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 months
Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
DLTs:Incidence of Dose Limiting Toxicities
Time frame: From Baseline up to 4 weeks
Phase Ia:Maximum Tolerated Dose (MTD) of MBS314
MTD:Maximum Tolerated Dose
Time frame: Up to approximately 11 months
Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314
RP2D: Recommended Phase II Dose
Time frame: Up to approximately 29 months
Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
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.
Time frame: Up to approximately 4 years
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 year
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.
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Time frame: Up to approximately 4 year
Efficacy: Minimal Residual Disease (MRD) Negative Rate
Minimal Residual Disease (MRD) Negative Rate
Time frame: Up to approximately 4 years
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 year