A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.

Phase 1

Recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: MBS314 Injection

• Registration Number: NCT06232096
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Study Start: 2024-02-22
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-02
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBS314	MBS314 Injection	-

Primary Outcome Measures

Name	Time	Method
Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)	From Baseline up to 4 weeks	DLTs:Incidence of Dose Limiting Toxicities
Phase Ia:Maximum Tolerated Dose (MTD) of MBS314	Up to approximately 11 months	MTD:Maximum Tolerated Dose
Phase Ia:Percentage of Participants with Adverse Events (AEs) .	From Baseline up to approximately 29 months	Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314	Up to approximately 29 months	RP2D: Recommended Phase II Dose
Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy: Stringent Complete Response (sCR) Rate	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.
Efficacy: Minimal Residual Disease (MRD) Negative Rate	Up to approximately 4 years	Minimal Residual Disease (MRD) Negative Rate
Efficacy: Complete Response (CR) or Better Rate	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.
Efficacy: Very Good Partial Response (VGPR) or Better Rate	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.

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital; 🇨🇳 Beijing, China