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This is a Phase I/â…¡, 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 â… a) and an expansion part (Phase â… b/â…¡).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBS314 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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/â…¡: Based on the results of Phase â… a, 1 or 2 recommended doses will be selected for Phase â… b. Recommended Phase II Dose (RP2D) will be selected for Phase â…¡. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 â…¡ Dose (RP2D) of MBS314 | RP2D: Recommended Phase II Dose | Up to approximately 29 months |
| Phase Ib/â…¡ :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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Efficacy: Complete Response (CR) or Better Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lugui Qiu, Doctor | Contact | 0086-022-23608560 | Qiulg@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu, Doctor | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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|
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 |
| Efficacy: Minimal Residual Disease (MRD) Negative Rate | Minimal Residual Disease (MRD) Negative Rate | 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. | Up to approximately 4 year |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |