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

NCT ID: NCT06232096

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2028-03-31

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).

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBS314

Group Type: EXPERIMENTAL

MBS314 Injection

Intervention Type: DRUG

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.

Interventions

MBS314 Injection

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lugui Qiu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology and Blood Diseases Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lugui Qiu, Doctor

Role: CONTACT

Qiulg@ihcams.ac.cn

0086-022-23608560

Facility Contacts

Lugui Qiu, Doctor

Role: primary

0086-022-23608560

Other Identifiers

MBS314-CT101

Identifier Type: -

Identifier Source: org_study_id