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Trial Title:
A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
NCT ID:
NCT06232096
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MBS314 Injection
Description:
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.
Arm group label:
MBS314
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide written informed consent and to comply with the study
protocol;
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 Criteria:
1. Known active central nervous system (CNS) involvement or exhibits clinical signs of
meningeal 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 C
virus RNA).
4. Previously received anti-myeloma treatment within the specified time frame prior to
the first administration.
5. Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or
expected to receive live, attenuated vaccines during the study period.
6. Major surgery within 28 days prior to the first infusion of MBS314, or expected to
undergo 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 or
hypersensitivity to any components of MBS314.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lugui Qiu, Doctor
Phone:
0086-022-23608560
Start date:
February 22, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Beijing Mabworks Biotech Co., Ltd.
Agency class:
Industry
Source:
Beijing Mabworks Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06232096
