Relapsed or Refractory Multiple Myeloma
Conditions
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).
Interventions
DRUGMBS314 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/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.
Sponsors
Beijing Mabworks Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ia:Percentage of Participants with Adverse Events (AEs) . | 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) | From Baseline up to 4 weeks | DLTs:Incidence of Dose Limiting Toxicities |
| Phase Ia:Maximum Tolerated Dose (MTD) of MBS314 | Up to approximately 11 months | MTD:Maximum Tolerated Dose |
| Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Stringent Complete Response (sCR) Rate | Up to approximately 4 year | sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to the IMWG response criteria. |
| Efficacy: Complete Response (CR) or Better Rate | Up to approximately 4 year | 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. |
| Efficacy: Minimal Residual Disease (MRD) Negative Rate | Up to approximately 4 years | Minimal Residual Disease (MRD) Negative Rate |
| Efficacy: Very Good Partial Response (VGPR) or Better Rate | Up to approximately 4 year | VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to the IMWG response criteria. |
Countries
China
Contacts
Primary ContactLugui Qiu, Doctor
Outcome results
None listed