Institute of Hematology and Blood Diseases Hospital
Beijing, China
Location status: Recruiting
NCT Number: NCT06232096
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From Baseline up to approximately 29 months
Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
Time frame: From Baseline up to 4 weeks
DLTs:Incidence of Dose Limiting Toxicities
Time frame: Up to approximately 11 months
MTD:Maximum Tolerated Dose
Time frame: Up to approximately 29 months
RP2D: Recommended Phase II Dose
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.
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.
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.
Time frame: Up to approximately 4 years
Minimal Residual Disease (MRD) Negative 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.
Contact information is provided by the study sponsor or research team.
Beijing Mabworks Biotech Co., Ltd.
Industry
A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
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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