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

Relapsed or Refractory Multiple Myeloma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232096
• Other study ID #: MBS314-CT101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 22, 2024
• Est. completion date: March 2028

Study information

• Verified date: December 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: Lugui Qiu, Doctor
• Phone: 0086-022-23608560
• Email: Qiulg[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: March 2028
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?b/?: 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• 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/?: Based on the results of Phase ?a, 1 or 2 recommended doses will be selected for Phase ?b. Recommended Phase II Dose (RP2D) will be selected for Phase ?.

Locations

Country	Name	City	State
China	Institute of Hematology and Blood Diseases Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)	DLTs:Incidence of Dose Limiting Toxicities	From Baseline up to 4 weeks
Primary	Phase Ia:Maximum Tolerated Dose (MTD) of MBS314	MTD:Maximum Tolerated Dose	Up to approximately 11 months
Primary	Phase Ia:Recommended Phase ? Dose (RP2D) of MBS314	RP2D: Recommended Phase II Dose	Up to approximately 29 months
Primary	Phase Ib/? :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	Efficacy: Stringent Complete Response (sCR) Rate	sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to the IMWG response criteria.	Up to approximately 4 year
Secondary	Efficacy: Complete Response (CR) or Better Rate	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.	Up to approximately 4 year
Secondary	Efficacy: Minimal Residual Disease (MRD) Negative Rate	Minimal Residual Disease (MRD) Negative Rate	Up to approximately 4 years
Secondary	Efficacy: Very Good Partial Response (VGPR) or Better Rate	VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to the IMWG response criteria.	Up to approximately 4 year