A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.

A Multicenter, Randomized, Controlled, Open Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy.

To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy

Study Overview

• Status: Recruiting
• Conditions: Primary Membranous Nephropathy
• Intervention / Treatment: Drug: B007; Drug: Cyclosporin Capsules

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Minghui Zhao; Phone Number: 0086- 010-66119025; Email: bdyyec@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University First Hospital
    • Contact: Minghui Zhao
  • Beijing, China
    • Recruiting
    • Beijing Tsinghua Changgung Hospital
    • Contact: Yuehong Li
  • Changchun, China
    • Recruiting
    • The Second Norman Bethune Hospital of Jilin University
    • Contact: Ping Luo
  • Guangzhou, China
    • Recruiting
    • ZhuJiang Hospital of Southern Medical University
    • Contact: Haibo Long
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital, Sun Yat-sen University
    • Contact: Wei Chen
  • Hangzhou, China
    • Recruiting
    • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: Heng Li
  • Hangzhou, China
    • Recruiting
    • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
    • Contact: Hua Li
  • Jinan, China
    • Recruiting
    • Shandong Provincial Hospital
    • Contact: Rong Wang
  • Nanning, China
    • Recruiting
    • The First Affiliated Hospital of Guangxi Medical University
    • Contact: Zhenhua Yang
  • Nantong, China
    • Recruiting
    • Affiliated Hospital of Nantong University
    • Contact: Xinzhong Huang
  • Qingdao, China
    • Recruiting
    • The Affiliated Hospital Of Qingdao University
    • Contact: Guangqun Xing
  • Shenyang, China
    • Recruiting
    • Shengjing Hospital affiliated to China Medical University
    • Contact: Hua Zhou
  • Shenyang, China
    • Recruiting
    • Northern Theater Command General Hospital
    • Contact: Yanning Zhang
  • Shenzhen, China
    • Recruiting
    • Peking University Shenzhen Hospital
    • Contact: Zibo Xiong
  • Wuhan, China
    • Recruiting
    • Renmin Hospital of Wuhan University
    • Contact: Dingping Yang
  • Wuxi, China
    • Recruiting
    • Wuxi People's Hospital
    • Contact: Bin Liu
  • Xi'an, China
    • Recruiting
    • Xi'an Daxing Hospital
    • Contact: Chengqun Zhao
  • Xingtai, China
    • Recruiting
    • The Second Affiliated Hospital of Xingtai Medical College
    • Contact: Huixiao Zheng
  • Yangzhou, China
    • Recruiting
    • Northern Jiangsu People's Hospital
    • Contact: Guangyu Bi
  • Yantai, China
    • Recruiting
    • Yantai Yuhuangding Hospital
    • Contact: Peng Li
  • Zigong, China
    • Recruiting
    • The First People's Hospital of Zigong
    • Contact: Yan Hao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
2. Subjects with glomerular filtration rate（eGFR） ≥ 45 mL/min/1.73 m2.
3. If taking Angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization;
4. Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;
5. Subjects whose laboratory test results meet the prescribed standards during the screening period;
6. Subjects who have fully understood this study and voluntarily signed the informed consent form；
7. Subjects who are able to follow the study protocol as judged by the investigator.

Exclusion Criteria:

1. Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;
2. Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;
3. Subjects who have received medication prescribed for membranous nephropathy;
4. Subjects with concomitant prescribed diseases;
5. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
6. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
7. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases;
8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
9. Subjects with CD4+ T lymphocyte count < 400 cells/μL;
10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
11. For male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses;
12. Other conditions unsuitable for participation in this study determined by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B007	Drug: B007; B007： Subcutaneous injection was administered on days 1 and 15
Active Comparator: Cyclosporin Capsules	Drug: Cyclosporin Capsules; Cyclosporin Capsules： Orally, 3.5 mg/kg/d；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ORR（Overall Remission Rate）	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
CRR（Complete Remission Rate）	Approximately 2 years
PRR（Partial Remission Rate）	Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Approximately 2 years

Collaborators and Investigators

• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
• Collaborators: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, Membranous; Peptides; Amino Acids, Peptides, and Proteins; Polycyclic Compounds; Macrocyclic Compounds; Peptides, Cyclic; Cyclosporins; Cyclosporine
• Other Study ID Numbers: SPH-B007-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No