Clinical trials: sponsored by Beijing Mabworks Biotech Co., Ltd.
Systemic Lupus Erythematosus
A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus
This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
- Trial name
- NCT05796206
- Testing
- MIL62
- Where
- China
- Volunteers
- 123 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Systemic Lupus Erythematosus
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
- Trial name
- NCT07405970
- Testing
- MIL62
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Immunoglobulin A Nephropathy
A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.
This is a Phase I/II study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy.
- Trial name
- NCT07375758
- Testing
- MIL116
- Where
- China
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Primary Membranous Nephropathy
A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy
This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in each group.
- Trial name
- NCT05398653
- Testing
- MIL62, Cyclosporine
- Where
- China
- Volunteers
- 94 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Neuromyelitis Optica Spectrum Disorder
A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
- Trial name
- NCT05314010
- Testing
- MIL62
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Primary Membranous Nephropathy
A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy
This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics（PD）and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).
- Trial name
- NCT05862233
- Testing
- MIL62, Cyclosporine
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Lupus Nephritis
Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study).
- Trial name
- NCT07044115
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Where
- China
- Volunteers
- 41 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
CD20-positive B Cell Non-Hodgkin Lymphoma
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin…
- Trial name
- NCT04103905
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Advanced Malignancies
A Clinical Study of MIL95 in Advanced Malignancies.
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
- Trial name
- NCT04651348
- Testing
- Recombinant Humanized Monoclonal Antibody MIL95
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
HER2-positive Recurrent or Metastatic Malignant Solid Tumor
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
- Trial name
- NCT03842085
- Testing
- Recombinant Humanized Bispecific Monoclonal Antibody MBS301
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Non-Hodgkin's Lymphoma
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
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 T-Cell bispecific (TCB), MBS303, administered…
- Trial name
- NCT05806099
- Testing
- MBS303
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Follicular Lymphoma and Marginal Zone Lymphoma
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab.
- Trial name
- NCT04834024
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide, lenalinomide
- Where
- China
- Volunteers
- 168 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Follicular Lymphoma and Marginal Zone Lymphoma
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and…
- Trial name
- NCT04110301
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62 Injection, Lenalidomide
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Relapsed or Refractory Multiple Myeloma
A Study of MBS314 in Participants 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…
- Trial name
- NCT06232096
- Testing
- MBS314 Injection
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Advanced or Metastatic Solid Tumor
Treatment of Advanced and Metastatic Solid Tumors With MIL97
This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid…
- Trial name
- NCT04965077
- Testing
- Recombinant Humanized Monoclonal Antibody MIL97 for Injection
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Advanced Malignancies
A Clinical Study of MIL93 in Solid Tumors.
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid…
- Trial name
- NCT04671875
- Testing
- Recombinant Humanized Monoclonal Antibody MIL93
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Non-small Cell Lung Cancer
mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer
This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in…
- Trial name
- NCT03196986
- Testing
- mil60, Bevacizumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.