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

NCT06232096 | Recruiting Phase 1 DMC

• 1 other identifier: MBS314-CT101
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Phase Ia:Percentage of Participants with Adverse Events (AEs) .

  Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.

  From Baseline up to approximately 29 months

• Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)

  DLTs:Incidence of Dose Limiting Toxicities

  From Baseline up to 4 weeks

• Phase Ia:Maximum Tolerated Dose (MTD) of MBS314

  MTD:Maximum Tolerated Dose

  Up to approximately 11 months

• Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314

  RP2D: Recommended Phase II Dose

  Up to approximately 29 months

• Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)

  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.

  Up to approximately 4 years

Secondary Outcomes (4)

• Efficacy: Stringent Complete Response (sCR) Rate

  Up to approximately 4 year

• Efficacy: Complete Response (CR) or Better Rate

  Up to approximately 4 year

• Efficacy: Minimal Residual Disease (MRD) Negative Rate

  Up to approximately 4 years

• Efficacy: Very Good Partial Response (VGPR) or Better Rate

  Up to approximately 4 year

Study Arms (1)

MBS314

EXPERIMENTAL

Drug: MBS314 Injection

Interventions

MBS314 Injection 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.

MBS314

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol;
• ≥18 years of age;
• Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.
• 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)
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy ≥3 months.
• Adequate hematologic, hepatic, and renal function.

You may not qualify if:

• Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• Participants with known active infection within 14 days prior to the first MBS314.
• 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).
• Previously received anti-myeloma treatment within the specified time frame prior to the first administration.
• Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.
• Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.
• Participants with a history of autoimmune diseases.
• Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Lugui Qiu, Doctor

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lugui Qiu, Doctor

CONTACT

0086-022-23608560; Qiulg@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: February 22, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)