Clinical trial NCT06232096: A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-30
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: Phase Ia:Percentage of Participants with Adverse Events (AEs) .
timeFrame: From Baseline up to approximately 29 months
measure: Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: From Baseline up to 4 weeks
measure: Phase Ia:Maximum Tolerated Dose (MTD) of MBS314
timeFrame: Up to approximately 11 months
measure: Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314
timeFrame: Up to approximately 29 months
measure: Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Efficacy: Stringent Complete Response (sCR) Rate
timeFrame: Up to approximately 4 year
measure: Efficacy: Complete Response (CR) or Better Rate
timeFrame: Up to approximately 4 year
measure: Efficacy: Minimal Residual Disease (MRD) Negative Rate
timeFrame: Up to approximately 4 years
measure: Efficacy: Very Good Partial Response (VGPR) or Better Rate
timeFrame: Up to approximately 4 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Hematology and Blood Diseases Hospital
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Lugui Qiu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: