Anti IL-6RPhase 3NCT07872423
Phase III Trial of VDJ001 In Patients With Idiopathic Multicentric Castleman Disease
A Phase 3 study testing Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection in people with Anti IL-6R and Castleman's Disease, Multicentric, run by Beijing VDJBio Co., LTD. at 8 sites in China.
Trial summary
This study adopted a multicenter, randomized, double-blind, placebo-controlled approach with the best supportive treatment design, using recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) to treat idiopathic multicenter Castleman disease (iMCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti IL-6R, Castleman's Disease, Multicentric
- What is being tested?
- Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 8 sitesChina
- Study dates
- 27 Jan 2025to 30 Jun 2027
- Phase
- Phase 3
- 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
- Age ≥18 years, regardless of gender;
- Biopsy or central pathological examination confirmed measurable, symptomatic iMCD (diagnosed according to the guideline for the diagnosis and treatment of Castleman disease in China (2025 )), with the patient presenting at least one of the following symptoms: fatigue, anorexia, fever, or weight loss;
- Clinical laboratory values within 4 weeks prior to the first dose meeting the following criteria:
- Absolute neutrophil count (ANC) ≥1.0×10⁹/L;
- Platelet count (PLT) ≥75×10⁹/L;
- Alanine aminotransferase (ALT) <2.5×ULN;
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- Total bilirubin (TBIL) <2.5×ULN;
- Serum creatinine (SCr) ≤3.0 mg/dL (265 μmol/L).
- ECOG-PS performance status score of 0, 1, or 2;
- If corticosteroids are used (e.g., prednisone), the dose should not exceed 1 mg/kg/day (or equivalent dose of other corticosteroids, see appendix), and must have been stable or reduced within 4 weeks prior to the first dose;
- Patients of childbearing potential (male and female) must agree to use effective contraception during the trial and for 6 months after the last dose; males must not donate sperm and females must not donate oocyte during this period;
- The patient (or their legal guardian or impartial witness) must sign the informed consent form before any study-specific procedures are performed, indicating understanding of the study purpose and required procedures, and voluntary participation in the study.
Who cannot join
- Individuals positive for HIV or HHV-8;
- Those with skin lesions as the only measurable lesion;
- Patients with concurrent malignancies within 5 years prior to screening, except for the following: adequately treated basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix;
- Patients with concurrent diseases that may interfere with the study process or results, such as autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, adult-onset Still's disease, juvenile idiopathic arthritis, autoimmune lymphoproliferative syndrome), active systemic infection, poorly controlled diabetes, acute diffuse lung disease, active tuberculosis;
- History of uncontrolled cardiac disease, such as unstable angina, congestive heart failure, myocardial infarction within the past 12 months, hemodynamic instability, known left ventricular ejection fraction (LVEF) <40%, or clinically significant rhythm or conduction abnormalities;
- Patients with any of the following positive test results: HBsAg-positive with HBV-DNA titer >1000 IU/mL, hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab);
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- History of allogeneic transplantation (except corneal transplantation);
- History of paraneoplastic pemphigus or bronchiolitis obliterans;
- Patients with a history of bleeding:
- Intracranial hemorrhage within 6 months prior to screening;
- Active bleeding within 2 months prior to screening.
- History of cerebral infarction within 6 months prior to screening (except lacunar infarction);
- Patients who have received prohibited treatments or plan to use the following treatments during the study:
- Prior treatment with IL-6/IL-6R targeted therapy before the first dose;
- Other concomitant anti-tumor therapies for Castleman disease (e.g., anti-CD20 antibodies, chemotherapy) within 8 weeks prior to the first dose;
- Biologics such as anti-tumor necrosis factor-α (TNF-α) antibodies within 8 weeks prior to the first dose;
- Erythropoiesis-stimulating agents (ESAs) within 8 weeks prior to the first dose;
- Immunosuppressants (except stable doses of corticosteroids) within 4 weeks prior to the first dose;
- Any systemic therapy for Castleman disease within 4 weeks prior to the first dose;
- Major surgery or radiotherapy within 4 weeks prior to the first dose;
- Current use or planned use of strong CYP3A inhibitors/inducers during the study；
- Known history of severe infusion reactions to monoclonal antibodies or human albumin;
- Severe psychiatric disorders that may compromise compliance with treatment;
- Vaccination with live or attenuated live vaccines within 4 weeks prior to the first dose or planned vaccination during the trial;
- Pregnant or lactating females, or those planning pregnancy within 6 months after the last dose;
- Participation in other clinical trials within 1 month prior to the first dose;
- Any other condition deemed by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Jian Li, 8618610852525, lijian@pumch.cn
- Not yet recruiting
Suncy0618@163.Com
Chengdu, Sichuan
Yu Wu, 8618980601973, wu_yu@scu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
hongyan Tong, 8613958122357, hongyantong@aliyun.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Li Yu, 8618679124515, 2263193417@qq.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
lei Fan, 8613813976136, fanlei3014@126.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Liangming Ma, 8613513629908, maliangming620928@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Chunyan Sun, 8615342346782, suncy0618@163.com
- Not yet recruiting
Xiamen Branch，Zhongshan hospital，Fudan University
Xiamen, Fujian
Zheng Wei, 8613916563166, wei.zheng@zs-hospital.sh.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Tiral of Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection (VDJ001) in the Treatment of Idiopathic Multicentric Castleman Disease (iMCD)
This study adopted a multicenter, randomized, double-blind, placebo-controlled approach with the best supportive treatment design, using recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) to treat idiopathic multicenter Castleman disease (iMCD).
- Conditions
- Anti IL-6R, Castleman's Disease, Multicentric
- Being tested
- Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection, Placebo
- Medical subject headings
- Multi-centric Castleman's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody InjectionDrug
VDJ001 is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). It is produced using Chinese hamster ovary (CHO) cells through DNA recombinant technology. The antibody specifically binds to both soluble and membrane-bound IL-6R (sIL-6R and mIL-6R), thereby inhibiting signal transduction mediated by sIL-6R or mIL-6R.
PlaceboDrug
This is a matching placebo formulation containing no active pharmaceutical ingredient (API). The placebo is manufactured to be identical in appearance, color, shape, size, taste, and packaging to the investigational product VDJ001 to maintain the integrity of the double-blind design. It is utilized solely as a control intervention for the purpose of this randomized, double-blind, placebo-controlled clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection | Experimental | Not described Receives: Drug: Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a comprehensive response, defined as complete response (CR) or partial response (PR), sustained for at least 18 weeks, based on combined assessment of symptoms, biochemical efficacy, and overall lymph node evaluation.
Measured: 30/36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start27 Jan 2025
- Primary completion9 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti IL-6RStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing VDJBio Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872423
- Sponsor's protocol ID
- VDJ001-MCD-Ⅲ
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Tiral of Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection (VDJ001) in the Treatment of Idiopathic Multicentric Castleman Disease (iMCD)
- ClinicalTrials.gov ID
- NCT07872423
- Acronym / sponsor ID
- VDJ001-MCD-Ⅲ
- Conditions
- Anti IL-6R, Castleman's Disease, Multicentric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beijing VDJBio Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 9 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Oct 2026 (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 study adopted a multicenter, randomized, double-blind, placebo-controlled approach with the best supportive treatment design, using recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) to treat idiopathic multicenter Castleman disease (iMCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection | Experimental | Drug: Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years, regardless of gender;
- Biopsy or central pathological examination confirmed measurable, symptomatic iMCD (diagnosed according to the guideline for the diagnosis and treatment of Castleman disease in China (2025 )), with the patient presenting at least one of the following symptoms: fatigue, anorexia, fever, or weight loss;
- Clinical laboratory values within 4 weeks prior to the first dose meeting the following criteria:
- ECOG-PS performance status score of 0, 1, or 2;
- If corticosteroids are used (e.g., prednisone), the dose should not exceed 1 mg/kg/day (or equivalent dose of other corticosteroids, see appendix), and must have been stable or reduced within 4 weeks prior to the first dose;
Key exclusion criteria (27 listed)
- Individuals positive for HIV or HHV-8;
- Those with skin lesions as the only measurable lesion;
- Patients with concurrent malignancies within 5 years prior to screening, except for the following: adequately treated basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix;
- Patients with concurrent diseases that may interfere with the study process or results, such as autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, adult-onset Still's disease, juvenile idiopathic arthritis, autoimmune lymphoproliferative syndrome), active systemic infection, poorly controlled diabetes, acute diffuse lung disease, active tuberculosis;
- History of uncontrolled cardiac disease, such as unstable angina, congestive heart failure, myocardial infarction within the past 12 months, hemodynamic instability, known left ventricular ejection fraction (LVEF) <40%, or clinically significant rhythm or conduction abnormalities;
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 |
|---|---|---|
| Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody InjectionVDJ001 is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). It is produced using Chinese hamster ovary (CHO) cells through DNA recombinant technology. The antibody specifically binds to both soluble and membrane-bound IL-6R (sIL-6R and mIL-6R), thereby inhibiting signal transduction mediated by sIL-6R or mIL-6R. | Drug | Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection |
| PlaceboThis is a matching placebo formulation containing no active pharmaceutical ingredient (API). The placebo is manufactured to be identical in appearance, color, shape, size, taste, and packaging to the investigational product VDJ001 to maintain the integrity of the double-blind design. It is utilized solely as a control intervention for the purpose of this randomized, double-blind, placebo-controlled clinical trial. | Drug | Placebo |
Primary outcome
Proportion of patients achieving a comprehensive response, defined as complete response (CR) or partial response (PR), sustained for at least 18 weeks, based on combined assessment of symptoms, biochemical efficacy, and overall lymph node evaluation.
Time frame: 30/36 weeks
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 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Anti IL-6R
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Active, not recruitingPhase 2
A Study of Anti-IL-6R mAb Injection in Patients With iMCD
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Active, not recruitingPhase 3
A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab When Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects With Active Rheumatoid Arthritis
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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.
Xiamen Branch，Zhongshan hospital，Fudan University
Xiamen, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Humanized Anti-Interleukin-6 Receptor Monoclonal Antibody Injection in people with Anti IL-6R and Castleman's Disease, Multicentric, run by Beijing VDJBio Co., LTD. at 8 sites 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 12 inclusion and 27 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving a comprehensive response, defined as complete response (CR) or partial response (PR), sustained for at least 18 weeks, based on combined assessment of symptoms, biochemical efficacy, and overall lymph node evaluation. (time frame: 30/36 weeks). 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 13 Oct 2026.