---
title: A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
nct_id: NCT06232096
overall_status: RECRUITING
phase: PHASE1, PHASE2
sponsor: Beijing Mabworks Biotech Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Relapsed or Refractory Multiple Myeloma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06232096.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06232096"
ct_last_update_post_date: 2024-03-15
last_seen_at: "2026-05-12T06:59:25.214Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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.

**NCT ID:** [NCT06232096](https://clinicaltrials.gov/study/NCT06232096)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 154
- **Lead Sponsor:** Beijing Mabworks Biotech Co., Ltd.
- **Conditions:** Relapsed or Refractory Multiple Myeloma
- **Start Date:** 2024-02-22
- **Completion Date:** 2028-03
- **CT.gov Last Update:** 2024-03-15

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **MBS314** (EXPERIMENTAL)

## 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.

## Primary Outcomes

- **Phase Ia:Percentage of Participants with Adverse Events (AEs) .** _(time frame: From Baseline up to approximately 29 months)_ — Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
- **Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)** _(time frame: From Baseline up to 4 weeks)_ — DLTs:Incidence of Dose Limiting Toxicities
- **Phase Ia:Maximum Tolerated Dose (MTD) of MBS314** _(time frame: Up to approximately 11 months)_ — MTD:Maximum Tolerated Dose
- **Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314** _(time frame: 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)** _(time frame: 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 Outcomes

- **Efficacy: Stringent Complete Response (sCR) Rate** _(time frame: Up to approximately 4 year)_
- **Efficacy: Complete Response (CR) or Better Rate** _(time frame: Up to approximately 4 year)_
- **Efficacy: Minimal Residual Disease (MRD) Negative Rate** _(time frame: Up to approximately 4 years)_
- **Efficacy: Very Good Partial Response (VGPR) or Better Rate** _(time frame: Up to approximately 4 year)_

## Locations (1)

- Institute of Hematology and Blood Diseases Hospital, Beijing, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.institute of hematology and blood diseases hospital|beijing||china` — added _(2026-05-12)_

---

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