Relapsed or Refractory Multiple MyelomaPhase 1/2NCT06232096
A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
A Phase 1/2 study testing MBS314 Injection in people with Relapsed or Refractory Multiple Myeloma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- MBS314 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2024to Mar 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;
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital
Beijing
Lugui Qiu, Doctor, 0086-022-23608560
About this study
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.
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
- Being tested
- MBS314 Injection
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS314 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MBS314 | Experimental | Not described Receives: Drug: MBS314 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia:Percentage of Participants with Adverse Events (AEs) .
Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
Measured: From Baseline up to approximately 29 months
Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
DLTs:Incidence of Dose Limiting Toxicities
Measured: From Baseline up to 4 weeks
Phase Ia:Maximum Tolerated Dose (MTD) of MBS314
MTD:Maximum Tolerated Dose
Measured: Up to approximately 11 months
Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314
RP2D: Recommended Phase II Dose
Measured: 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.
Measured: Up to approximately 4 years
Secondary outcomes (4)
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.
Measured: Up to approximately 4 year
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.
Measured: Up to approximately 4 year
Efficacy: Minimal Residual Disease (MRD) Negative Rate
Minimal Residual Disease (MRD) Negative Rate
Measured: Up to approximately 4 years
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.
Measured: Up to approximately 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start22 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Doctor, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232096
- Sponsor's protocol ID
- MBS314-CT101
- Status last verified
- Dec 2023
- First submitted
- 22 Jan 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. 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 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT06232096
- Acronym / sponsor ID
- MBS314-CT101
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Jan 2024 (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 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).
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 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 InjectionPhase 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. | Drug | MBS314 |
Primary outcome
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.
4 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
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 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Lugui Qiu, Doctor principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MBS314 Injection in people with Relapsed or Refractory Multiple Myeloma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lugui Qiu, Doctor (0086-022-23608560, Qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia:Percentage of Participants with Adverse Events (AEs) . (time frame: From Baseline up to approximately 29 months). 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 15 Mar 2024.