Idiopathic Multicentric Castleman's DiseasePhase 2NCT05345522
A Study of Anti-IL-6R mAb Injection in Patients With iMCD
A Phase 2 study testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w and Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w in people with Idiopathic Multicentric Castleman's Disease, run by Beijing VDJBio Co., LTD. at 3 sites in China.
Trial summary
This study is a single-arm, open-label, multicenter, dose-escalation clinical study. Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD )… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Multicentric Castleman's Disease
- What is being tested?
- Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w and Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesChina
- Study dates
- 18 Apr 2022to 31 Dec 2025
- Phase
- Phase 2
- 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 old, gender is not limited;
- Biopsy or center pathology examination confirmed the measurable, symptomatic iMCD (iMCD diagnosis based on The consensus of the diagnosis and treatment of Castleman disease in China (2021));
- Clinical laboratory test values within 4 weeks before treatment meet the following criteria:
- Absolute neutrophil count (ANC)≥1.0×10^9/L; Platelet count (Plt) ≥ 75×10^9/L; Alanine aminotransferase (ALT) < 2.5×upper limit of normal (ULN) ; Total bilirubin (TBIL) <2.5×ULN; Serum creatinine (Scr) ≤ 3.0 mg/dL (265 umol/L).
- ECOG-PS physical status score of 0, 1 or 2 points;
- When using corticosteroids, the dose of prednisone should not exceed 1 mg/kg/day (or equivalent dose), and the dose should be maintained or reduced within 4 weeks before the first dose;
- Patients of childbearing age (males and females) must agree to take effective contraceptive measures during the trial and within 3 months after the last medication, males are not allowed to donate sperm, and females are not allowed to donate eggs;
- The patients themselves (or their legally recognized representatives) must sign an informed consent form before performing any research-specific procedures, indicating that they understand the purpose of the research and the procedures that need to be performed, and voluntarily participate in this research.
Who cannot join
- Human immunodeficiency virus (HIV) or human herpesvirus 8 (HHV-8) positive;
- Skin lesions are the only detectable lesions;
- Patients with concurrent malignant tumors (disease-free time < 5 years), except for the following cases: fully treated skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ;
- Patients with diseases that may interfere with the research process or research results, such as autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, adult Still's disease, juvenile idiopathic arthritis, autoimmune lymphoproliferative syndrome) ), active systemic infection, poorly controlled diabetes, acute diffuse infiltrative lung disease;
- Those who use contraindicated treatments or plan to use the following treatments during the study period:
- Received IL-6 or IL-6R targeted drug therapy before the first dose; Received other concomitant anti-tumor therapy for Castleman's disease (such as anti-CD20 antibody, chemotherapy) within 8 weeks before the first dose; Received biologics such as anti-tumor necrosis factor-α (TNF-α) antibodies within 8 weeks before the first dose; Received immunosuppressive agents (other than stable doses of corticosteroids) within 8 weeks prior to the first dose; Received erythropoiesis-stimulating agents (ESAs) within 8 weeks prior to the first dose; Received any systemic therapy for Castleman's disease within 4 weeks prior to the first dose; Major surgery or radiotherapy within 4 weeks before the first dose; Are receiving or planning to receive treatment with a strong CYP3A inhibitor during the study period.
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- Uncontrolled history of heart disease, such as unstable angina, congestive heart failure, myocardial infarction within the past 12 months, hemodynamic instability or known left ventricular ejection fraction (LVEF) <40% or clinically significant cardiac rhythm or conduction abnormalities;
- Persons with positive infectious disease test (positive hepatitis B surface antigen (HBsAg) and hepatitis B virus-DNA titer>1000IU/ml, hepatitis C virus , syphilis, active pulmonary tuberculosis);
- History of allogeneic transplantation (except corneal transplantation);
- Those who are known to have severe infusion reactions to monoclonal antibodies or murine, chimeric or human proteins;
- Pregnant or lactating women, or those who plan to become pregnant within 3 months after the last dose;
- Those who have been vaccinated with the new coronavirus vaccine or other live attenuated vaccines within 4 weeks before the first administration, or who plan to be vaccinated during the trial period;
- Those who have participated in other clinical trials within 1 month before the first administration;
- Patients with paraneoplastic pemphigus or bronchiolitis obliterans;
- Patients with a history of bleeding，including:
- Intracranial hemorrhage within 6 months before screening; Active bleeding within 2 months prior to screening.
- Patients with cerebral infarction within 6 months before screening (except lacunar infarction);
- Any other circumstances judged by the investigator to be inappropriate to participate in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
West China Hospital of Sichuan Hospital
Chengdu
About this study
Official title: A Single-arm, Open-label, Multi-center Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-IL-6R mAb Injection in the Treatment of Patients With Idiopathic Multicentric Castleman's Disease
This study is a single-arm, open-label, multicenter, dose-escalation clinical study. Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD ) and to determine the recommended dose for follow-up studies. Its secondary purpose is to evaluate the preliminary efficacy, immunogenicity and pharmacokinetic ( PK ) index, pharmacodynamic ( PD ) characteristics of Anti-IL-6R mAb injection in patients with iMCD.
Read the detailed description
Phase I:
This stage is a single-arm, open-label, multicenter, dose-escalation clinical study. A total of 3 dose groups of 4 mg/kg, 6 mg/kg and 8 mg/kg, 3 patients per dose, are designed in this study to explore the safety, tolerability and preliminary efficacy of the experimental drug administered for ≥4 cycles in patients with iMCD. Referring to the inclusion and exclusion criteria, the patients will be enrolled from the low-dose group to the high-dose group in turn. After the last patient of each dose group completed the third administration and 2-week safety observation, the investigator and the sponsor will discuss the safety results of the patients together in this dose group. If no any important adverse event occurs, they can enter the next dose group. If an important adverse event occurs in any patient, the investigator and the sponsor will discuss whether to continue the study in the next dose group. Dose escalation will be discontinued if more than one patient experiences an important adverse event. If an important adverse event occurs, the investigator will perform related inspections based on the patient's condition, and for treatment.
After the patient completes four cycles of administration, if no significant safety events are found or the patient has not withdrawn from the trial due to significant safety events and has a significant treatment effect, and if the investigator determines that they may benefit from continuing the treatment, with the consent of both the investigator and the patient.
Phase I is planned to include 9 patients.
Phase II:
This stage is a single-arm, open-label, multicenter clinical study. Based on the analysis of all patients' data up to C10D14 from the first stage, it is planned to further explore the dosing regimens of 4 mg/kg and 6 mg/kg in this stage. A total of two groups are set up. Group 1: 4 mg/kg, 1 cycle every 3 weeks, 1 dose per cycle, administered on the first day of each cycle, if the investigator assesses that the poor efficacy may be caused by insufficient dose, after communication with the sponsor, the patient can be transferred to the 6 mg/kg dose group for continued treatment observation to explore the safety and preliminary efficacy of the investigational drug when administered for ≥ 4 cycles in iMCD patients; Group 2: 6 mg/kg, 1 cycle every 3 weeks, 1 dose per cycle, administered on the first day of each cycle, to explore the safety and preliminary efficacy of the investigational drug when administered for ≥ 4 cycles in iMCD patients. According to the inclusion and exclusion criteria, 8 patients were enrolled in each group 1 and group 2. Patients were enrolled in sequence according to the number, and the first 8 patients were enrolled in group 1, and the next 8 patients were enrolled in group 2.
After 4 cycles of administration in patients of group 1 or group 2, if the treatment effect is obvious and the investigator judges that the patient may benefit from continuing the treatment, with the consent of both the investigator and the patient, the patient enters the extension period.
Phase II is planned to include 16 patients.
- Being tested
- Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w
- Keywords
- anti IL-6R, iMCD
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 Injection 4 mg/kg, q2wBiological
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2wBiological
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2wBiological
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3wBiological
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, intravenous injection for 60 to 90 minutes. Every 3 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3wBiological
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, intravenous injection for 60 to 90 minutes. Every 3 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w | Experimental | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg as the low dose group in phase I. Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w | Experimental | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w as the middle dose group in phase I. Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w | Experimental | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w, as the high dose group in phase I. Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w | Experimental | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w, as the high dose group in phase II. Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg, q3w | Experimental | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg, q3w, as the low dose group in Phase II. Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events(AEs) as Assessed by CTCAE v5.0
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product. The AE can be any symptom, disease or abnormal laboratory finding, which does not necessarily have a causal relationship with this treatment.
Measured: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Grades of all the Adverse Events(AEs) by CTCAE v5.0
Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline.
Measured: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Secondary outcomes (9)
Percentage of Participants Who Achieved Overall Response Rate（ORR）for Biochemical Response
ORR is CR + PR. Biochemical indicators include 4 laboratory test indicators, namely C-reactive protein, hemoglobin, albumin and glomerular filtration rate. CR is the return of 4 biochemical indicators to normal. PR is a greater than 50% improvement in all four biochemical parameters.
Measured: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Percentage of Participants Who Achieved Overall Response Rate（ORR）for Lymph Nodes
ORR is Complete Response (CR) + Partial Response (PR) , assessed according to International Working Group ( IWG ) 1999 criteria.
Measured: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Percentage of Participants Who Achieved Overall Response Rate（ORR）for Symptomatic Response
ORR is CR + PR. The symptom response involves 4 symptoms, namely fatigue, anorexia, fever, and weight loss. CR is 4 symptoms returning to pre-onset. PR is improvement in all 4 symptoms, but not return to pre-onset.
Measured: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Concentration of Anti-Drug Antibody (ADA)
The concentrations of ADA in serum will be tested.
Measured: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Concentration of Neutralizing Antibody (NAb)
The concentration of NAb in serum will be tested when their ADA is positive.
Measured: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
The concentrations of sIL-6R in the serum of each subject are measured.
Measured: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Concentration of Interleukin-6 (IL-6)
The concentrations of IL-6 in the serum of each subject are measured.
Measured: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Cmax
Peak concentration. Obtain directly according to the measured data of blood concentration-time.
Measured: Through study completion, an average of 2 years in Phase I and 1 year in phase II
AUC0-t
The area under the curve from time zero to the last time that the blood drug concentration can be quantitatively detected.
Measured: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start18 Apr 2022
- Primary completion27 Nov 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Multicentric Castleman's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing VDJBio Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345522
- Sponsor's protocol ID
- VDJ001-MCD-Ⅱa
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2022
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multi-center Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-IL-6R mAb Injection in the Treatment of Patients With Idiopathic Multicentric Castleman's Disease
- ClinicalTrials.gov ID
- NCT05345522
- Acronym / sponsor ID
- VDJ001-MCD-Ⅱa
- Keywords
- anti IL-6R, iMCD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beijing VDJBio Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Apr 2022 (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 is a single-arm, open-label, multicenter, dose-escalation clinical study. Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD ) and to determine the recommended dose for follow-up studies. Its secondary purpose is to evaluate the preliminary efficacy, immunogenicity and pharmacokinetic ( PK ) index, pharmacodynamic ( PD ) characteristics of Anti-IL-6R mAb injection in patients with iMCD.
Detailed description
Phase I:
This stage is a single-arm, open-label, multicenter, dose-escalation clinical study. A total of 3 dose groups of 4 mg/kg, 6 mg/kg and 8 mg/kg, 3 patients per dose, are designed in this study to explore the safety, tolerability and preliminary efficacy of the experimental drug administered for ≥4 cycles in patients with iMCD. Referring to the inclusion and exclusion criteria, the patients will be enrolled from the low-dose group to the high-dose group in turn. After the last patient of each dose group completed the third administration and 2-week safety observation, the investigator and the sponsor will discuss the safety results of the patients together in this dose group. If no any important adverse event occurs, they can enter the next dose group. If an important adverse event occurs in any patient, the investigator and the sponsor will discuss whether to continue the study in the next dose group. Dose escalation will be discontinued if more than one patient experiences an important adverse event. If an important adverse event occurs, the investigator will perform related inspections based on the patient's condition, and for treatment.
After the patient completes four cycles of administration, if no significant safety events are found or the patient has not withdrawn from the trial due to significant safety events and has a significant treatment effect, and if the investigator determines that they may benefit from continuing the treatment, with the consent of both the investigator and the patient.
Phase I is planned to include 9 patients.
Phase II:
This stage is a single-arm, open-label, multicenter clinical study. Based on the analysis of all patients' data up to C10D14 from the first stage, it is planned to further explore the dosing regimens of 4 mg/kg and 6 mg/kg in this stage. A total of two groups are set up. Group 1: 4 mg/kg, 1 cycle every 3 weeks, 1 dose per cycle, administered on the first day of each cycle, if the investigator assesses that the poor efficacy may be caused by insufficient dose, after communication with the sponsor, the patient can be transferred to the 6 mg/kg dose group for continued treatment observation to explore the safety and preliminary efficacy of the investigational drug when administered for ≥ 4 cycles in iMCD patients; Group 2: 6 mg/kg, 1 cycle every 3 weeks, 1 dose per cycle, administered on the first day of each cycle, to explore the safety and preliminary efficacy of the investigational drug when administered for ≥ 4 cycles in iMCD patients. According to the inclusion and exclusion criteria, 8 patients were enrolled in each group 1 and group 2. Patients were enrolled in sequence according to the number, and the first 8 patients were enrolled in group 1, and the next 8 patients were enrolled in group 2.
After 4 cycles of administration in patients of group 1 or group 2, if the treatment effect is obvious and the investigator judges that the patient may benefit from continuing the treatment, with the consent of both the investigator and the patient, the patient enters the extension period.
Phase II is planned to include 16 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w | Experimental | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg as the low dose group in phase I. |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w | Experimental | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w as the middle dose group in phase I. |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w | Experimental | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w, as the high dose group in phase I. |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w | Experimental | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w, as the high dose group in phase II. |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg, q3w | Experimental | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg, q3w, as the low dose group in Phase II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old, gender is not limited;
- Biopsy or center pathology examination confirmed the measurable, symptomatic iMCD (iMCD diagnosis based on The consensus of the diagnosis and treatment of Castleman disease in China (2021));
- Clinical laboratory test values within 4 weeks before treatment meet the following criteria:
- Absolute neutrophil count (ANC)≥1.0×10^9/L; Platelet count (Plt) ≥ 75×10^9/L; Alanine aminotransferase (ALT) < 2.5×upper limit of normal (ULN) ; Total bilirubin (TBIL) <2.5×ULN; Serum creatinine (Scr) ≤ 3.0 mg/dL (265 umol/L).
- ECOG-PS physical status score of 0, 1 or 2 points;
Key exclusion criteria (18 listed)
- Human immunodeficiency virus (HIV) or human herpesvirus 8 (HHV-8) positive;
- Skin lesions are the only detectable lesions;
- Patients with concurrent malignant tumors (disease-free time < 5 years), except for the following cases: fully treated skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ;
- Patients with diseases that may interfere with the research process or research results, such as autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, adult Still's disease, juvenile idiopathic arthritis, autoimmune lymphoproliferative syndrome) ), active systemic infection, poorly controlled diabetes, acute diffuse infiltrative lung disease;
- Those who use contraindicated treatments or plan to use the following treatments during the study period:
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 Injection 4 mg/kg, q2wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles. | Biological | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles. | Biological | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles. | Biological | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, intravenous injection for 60 to 90 minutes. Every 3 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles. | Biological | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg, q3w |
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3wRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, intravenous injection for 60 to 90 minutes. Every 3 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles. | Biological | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w |
Primary outcome
Number of Participants with Adverse Events(AEs) as Assessed by CTCAE v5.0
Time frame: Through study completion, an average of 3 years in Phase I and 1 year in phase II
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product. The AE can be any symptom, disease or abnormal laboratory finding, which does not necessarily have a causal relationship with this treatment.
Grades of all the Adverse Events(AEs) by CTCAE v5.0
Time frame: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline.
9 secondary outcomes
Percentage of Participants Who Achieved Overall Response Rate（ORR）for Biochemical Response
Time frame: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Percentage of Participants Who Achieved Overall Response Rate（ORR）for Lymph Nodes
Time frame: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Percentage of Participants Who Achieved Overall Response Rate（ORR）for Symptomatic Response
Time frame: Through study completion, an average of 3 years in Phase I and 1 year in phase II
Concentration of Anti-Drug Antibody (ADA)
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Concentration of Neutralizing Antibody (NAb)
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Concentration of Interleukin-6 (IL-6)
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Cmax
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
AUC0-t
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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Castleman's Disease (CD), Idiopathic Multicentric Castleman's Disease
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. This study is not recruiting at the moment.
Jian li, M.D. principal investigator
Peking Union Medical College Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w, Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w and Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w in people with Idiopathic Multicentric Castleman's Disease, run by Beijing VDJBio Co., LTD. at 3 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 8 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events(AEs) as Assessed by CTCAE v5.0 (time frame: Through study completion, an average of 3 years in Phase I and 1 year in phase II). The study lists 2 primary outcomes in all. 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 8 Aug 2025.