Multiple MyelomaPhase 1/2NCT07911748
A Study of MBS314 for Injection in Participants With Relapsed/Refractory Multiple Myeloma.
A Phase 1/2 study testing MBS314 for Injection in people with Multiple Myeloma, run by Beijing Mabworks Biotech Co., Ltd..
Trial summary
This is a Phase I/II, multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MBS314, a novel asymmetric trivalent trispecific humanized antibody targeting GPRC5D, BCMA and CD3, administered by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- MBS314 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent and to comply with the study protocol;
- Phase I: 18-70 years of age (inclusive) at the time of signing ICF; Phase II: ≥18 years of age;
- Documented diagnosis of active or symptomatic multiple myeloma according to the 2014 IMWG diagnostic criteria; Phase I: at least 3 prior lines of systemic anti-myeloma therapy including at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD) and one anti-CD38 antibody, or no available standard treatment per investigator judgment, and relapsed or refractory to the last line of therapy or intolerant to prior treatment; Phase II: at least 2 prior lines including at least one PI, one IMiD and one anti-CD38 antibody, and relapsed or refractory to the last line of therapy or intolerant to prior treatment;
- At least one measurable disease at screening： 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.
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- Toxicity from prior anti-myeloma therapy recovered to Grade ≤1 per NCI CTCAE v6.0 (except alopecia, fatigue and Grade 2 peripheral neuropathy);
- Left ventricular ejection fraction (LVEF) ≥50%;
- Adequate hematologic, hepatic, renal and coagulation function: platelet count ≥75×10^9/L (or ≥50×10^9/L if ≥50% of bone marrow nucleated cells are plasma cells); absolute neutrophil count (NEUT) ≥1.5×10^9/L; hemoglobin ≥75 g/L; AST and ALT ≤2.5×ULN; total bilirubin ≤1.5×ULN (≤3×ULN for participants with Gilbert syndrome); serum creatinine ≤1.5×ULN or creatinine clearance ≥40 mL/min; INR or PT ≤1.5×ULN; APTT ≤1.5×ULN; corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L).
Who cannot join
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Active infection within 14 days prior to the first MBS314 administration requiring anti-infective treatment or hospitalization (including infections requiring IV antibiotics and/or hospitalization within 4 weeks, or oral antibiotics within 2 weeks prior to first dose); participants with a positive SARS-CoV-2 test result, with or without symptoms or suspected infection, are excluded;
- HBsAg and/or HBcAb positive with HBV DNA above the upper limit of normal; HCV antibody positive with HCV RNA above the upper limit of normal; HIV seropositive; Treponema pallidum antibody (TP-Ab) positive;
- Received the following anti-myeloma treatments within the specified time frame prior to the first administration: targeted therapy, immunotherapy, antibody drugs, cytotoxic drugs, antibody-drug conjugates, radiotherapy, tumor embolization, epigenetic therapy or investigational drugs (or invasive investigational medical devices) within 21 days or 5 half-lives (whichever is shorter); PIs within 14 days; IMiDs within 14 days; anti-tumor Chinese herbal medicines within 14 days; cell therapy (including but not limited to CAR-T, NK cells, neoantigen vaccines, etc.) or autologous hematopoietic stem cell transplantation within 3 months; prior allogeneic hematopoietic stem cell transplantation;
- Live, attenuated vaccines within 28 days prior to the first administration of MBS314, or expected to receive live, attenuated vaccines during the study period;
- Major surgery within 28 days prior to the first administration of MBS314, or expected to undergo major surgery during the study treatment, or with serious unhealed wounds, trauma or ulcers (except diagnostic biopsy and central venous catheterization);
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- History of autoimmune diseases (except participants with autoimmune-related hypothyroidism on a stable dose of thyroid replacement therapy, and participants with well-controlled type 1 diabetes);
- History of severe allergic reactions (≥Grade 3 per NCI CTCAE v6.0) to other antibody drugs, or known allergies or hypersensitivity to any components of MBS314;
- Smoldering multiple myeloma, plasma cell leukemia (plasma cells >2.0×10^9/L), Waldenström macroglobulinemia, POEMS syndrome, or concurrent primary or secondary amyloidosis;
- Prior treatment with agents targeting both BCMA and GPRC5D, including but not limited to BCMA/GPRC5D-targeted trispecific antibodies, chimeric antigen receptor T-cell (CAR-T) therapy, or simultaneous or sequential treatment with BCMA- and GPRC5D-targeted drugs; participants previously treated with only one of the BCMA or GPRC5D targets may enroll;
- Other severe, poorly controlled comorbidities that may affect protocol compliance or interpretation of results, including but not limited to: clinically significant valvular heart disease; history of congestive heart failure; angina requiring medication or unstable angina; NYHA Class III or higher cardiac dysfunction; QTcF ≥470 ms (female) or ≥450 ms (male) or history of congenital long QT syndrome; myocardial infarction or acute coronary syndrome within 6 months prior to screening; thromboembolic or vascular events within 6 months prior to screening; clinically significant arrhythmias; poorly controlled hypertension (SBP >160 mmHg or DBP >100 mmHg); poorly controlled diabetes (fasting glucose ≥10 mmol/L); clinically significant pulmonary disease; uncontrolled pleural, pericardial or peritoneal effusions requiring repeated drainage or medical intervention;
- Any other invasive malignancy within the past 3 years (except radically treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, breast or bladder, or other malignancy with low metastasis or death risk [5-year survival >90%]); progressive multifocal leukoencephalopathy; severe bleeding disorders such as hemophilia A, hemophilia B, von Willebrand disease, or spontaneous bleeding requiring transfusion or other medical intervention;
- Pregnant or lactating women; women of childbearing potential who do not agree to use appropriate contraception (e.g., oral contraceptives, intrauterine device, barrier contraception or spermicide) during the treatment period and for at least 6 months after the last dose of study drug;
- Men who do not agree to use barrier contraception during the treatment period and for at least 6 months after the last dose of study drug, and do not agree to have their partners use appropriate contraception;
- Any other condition that, in the judgment of the investigator, makes the participant unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 for Injection in Patients With Relapsed/Refractory Multiple Myeloma
This is a Phase I/II, multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MBS314, a novel asymmetric trivalent trispecific humanized antibody targeting GPRC5D, BCMA and CD3, administered by subcutaneous (SC) injection in participants with relapsed or refractory multiple myeloma. The investigational drug is MBS314 for Injection (high-concentration lyophilized formulation, 90 mg/vial, reconstituted to 90 mg/mL); this study is the first-in-human (FIH) study of this formulation. The study is divided into 2 parts: a dose escalation part (Phase I) and a dose expansion part (Phase II). In Phase I, eligible participants will be sequentially assigned to 1 of the 3 planned dose cohorts and receive MBS314 by SC injection using a step-up dosing (SUD) strategy, and dose escalation follows the Bayesian Optimal Interval (BOIN) design with a target toxicity rate of 33%. In Phase II, 1 to 3 dose groups will be selected based on Phase I results to further evaluate the efficacy of MBS314 at the recommended dose(s).
- Conditions
- Multiple Myeloma
- Being tested
- MBS314 for Injection
- Keywords
- Trispecific antibody, MBS314, Multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS314 for InjectionDrug
Phase I: Eligible participants will be sequentially assigned to one of three dose groups under BOIN design (Dose Group 1: 3-step SUD [0.5/3.0/15.0 mg], target dose 90.0 mg; Dose Group 2 [tentative]: 3-step SUD [1.5/9.0/45.0 mg], target dose 135.0 mg; Dose Group 3 [tentative]: 3-step SUD [2.5/15.0/90.0 mg], target dose 180.0 mg). MBS314 is given subcutaneously (single injection volume ≤2.0 mL; injection sites ≥2 cm apart). Step-up dosing is used in Cycle 1: priming doses on C1D1, C1D4, C1D7 and target dose on C1D10. From Cycle 2 onwards, target dose is administered Q4W.
Phase II: Based on Phase I findings, 1-3 dose groups will be selected for dose expansion (10-20 participants per group, total 10-60).
| Study group | Role | What they receive |
|---|---|---|
| MBS314 | Experimental | Not described Receives: Drug: MBS314 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I ：Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v6.0.
Measured: From Baseline up to 28 (+7) days after the last dose of MBS314]
Phase I：Incidence of Dose Limiting Toxicities (DLTs)
Measured: From Baseline up to 4 weeks
Phase I：Maximum Tolerated Dose (MTD) (if any) or Optimal Biological Dose (OBD) of MBS314
Measured: Up to approximately 7 months
Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS314
Measured: Up to approximately 7 months
Phase II：Efficacy: Overall Response Rate (ORR) as Assessed by the Investigator
ORR is defined as the proportion of participants who achieve sCR, CR, VGPR or PR according to the 2016 IMWG response criteria, as assessed by the investigator.
Measured: Up to approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911748
- Sponsor's protocol ID
- MBS314-CT103
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 for Injection in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07911748
- Acronym / sponsor ID
- MBS314-CT103
- Conditions
- Multiple Myeloma
- Keywords
- Trispecific antibody, MBS314, Multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II, multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MBS314, a novel asymmetric trivalent trispecific humanized antibody targeting GPRC5D, BCMA and CD3, administered by subcutaneous (SC) injection in participants with relapsed or refractory multiple myeloma. The investigational drug is MBS314 for Injection (high-concentration lyophilized formulation, 90 mg/vial, reconstituted to 90 mg/mL); this study is the first-in-human (FIH) study of this formulation. The study is divided into 2 parts: a dose escalation part (Phase I) and a dose expansion part (Phase II). In Phase I, eligible participants will be sequentially assigned to 1 of the 3 planned dose cohorts and receive MBS314 by SC injection using a step-up dosing (SUD) strategy, and dose escalation follows the Bayesian Optimal Interval (BOIN) design with a target toxicity rate of 33%. In Phase II, 1 to 3 dose groups will be selected based on Phase I results to further evaluate the efficacy of MBS314 at the recommended dose(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBS314 | Experimental | Drug: MBS314 for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able and willing to provide written informed consent and to comply with the study protocol;
- Phase I: 18-70 years of age (inclusive) at the time of signing ICF; Phase II: ≥18 years of age;
- Documented diagnosis of active or symptomatic multiple myeloma according to the 2014 IMWG diagnostic criteria; Phase I: at least 3 prior lines of systemic anti-myeloma therapy including at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD) and one anti-CD38 antibody, or no available standard treatment per investigator judgment, and relapsed or refractory to the last line of therapy or intolerant to prior treatment; Phase II: at least 2 prior lines including at least one PI, one IMiD and one anti-CD38 antibody, and relapsed or refractory to the last line of therapy or intolerant to prior treatment;
- At least one measurable disease at screening： 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.
Key exclusion criteria (15 listed)
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Active infection within 14 days prior to the first MBS314 administration requiring anti-infective treatment or hospitalization (including infections requiring IV antibiotics and/or hospitalization within 4 weeks, or oral antibiotics within 2 weeks prior to first dose); participants with a positive SARS-CoV-2 test result, with or without symptoms or suspected infection, are excluded;
- HBsAg and/or HBcAb positive with HBV DNA above the upper limit of normal; HCV antibody positive with HCV RNA above the upper limit of normal; HIV seropositive; Treponema pallidum antibody (TP-Ab) positive;
- Received the following anti-myeloma treatments within the specified time frame prior to the first administration: targeted therapy, immunotherapy, antibody drugs, cytotoxic drugs, antibody-drug conjugates, radiotherapy, tumor embolization, epigenetic therapy or investigational drugs (or invasive investigational medical devices) within 21 days or 5 half-lives (whichever is shorter); PIs within 14 days; IMiDs within 14 days; anti-tumor Chinese herbal medicines within 14 days; cell therapy (including but not limited to CAR-T, NK cells, neoantigen vaccines, etc.) or autologous hematopoietic stem cell transplantation within 3 months; prior allogeneic hematopoietic stem cell transplantation;
- Live, attenuated vaccines within 28 days prior to the first administration of MBS314, or expected to receive live, attenuated vaccines during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBS314 for InjectionPhase I: Eligible participants will be sequentially assigned to one of three dose groups under BOIN design (Dose Group 1: 3-step SUD [0.5/3.0/15.0 mg], target dose 90.0 mg; Dose Group 2 [tentative]: 3-step SUD [1.5/9.0/45.0 mg], target dose 135.0 mg; Dose Group 3 [tentative]: 3-step SUD [2.5/15.0/90.0 mg], target dose 180.0 mg). MBS314 is given subcutaneously (single injection volume ≤2.0 mL; injection sites ≥2 cm apart). Step-up dosing is used in Cycle 1: priming doses on C1D1, C1D4, C1D7 and target dose on C1D10. From Cycle 2 onwards, target dose is administered Q4W. Phase II: Based on Phase I findings, 1-3 dose groups will be selected for dose expansion (10-20 participants per group, total 10-60). | Drug | MBS314 |
Primary outcome
Phase I ：Percentage of Participants with Adverse Events (AEs)
Time frame: From Baseline up to 28 (+7) days after the last dose of MBS314]
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v6.0.
Phase I：Incidence of Dose Limiting Toxicities (DLTs)
Time frame: From Baseline up to 4 weeks
Phase I：Maximum Tolerated Dose (MTD) (if any) or Optimal Biological Dose (OBD) of MBS314
Time frame: Up to approximately 7 months
Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS314
Time frame: Up to approximately 7 months
Phase II：Efficacy: Overall Response Rate (ORR) as Assessed by the Investigator
Time frame: Up to approximately 15 months
ORR is defined as the proportion of participants who achieve sCR, CR, VGPR or PR according to the 2016 IMWG response criteria, as assessed by the investigator.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MBS314 for Injection in people with Multiple Myeloma, run by Beijing Mabworks Biotech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Du, Doctor (86+021-58752345, Juan_du@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I ：Percentage of Participants with Adverse Events (AEs) (time frame: From Baseline up to 28 (+7) days after the last dose of MBS314]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.