A Study of Anti-IL-6R mAb Injection in Patients With iMCD

NCT05345522 | Active Not Recruiting Phase 2

• 1 other identifier: VDJ001-MCD-Ⅱa
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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 ) 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.

Conditions

Idiopathic Multicentric Castleman's Disease

Keywords

anti IL-6R; iMCD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  Through study completion, an average of 3 years in Phase I and 1 year in phase II

• Concentration of Anti-Drug Antibody (ADA)

  Through study completion, an average of 2 years in Phase I and 1 year in phase II

• Concentration of Neutralizing Antibody (NAb)

  Through study completion, an average of 2 years in Phase I and 1 year in phase II

Study Arms (5)

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.

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.

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.

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.

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.

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3w

Interventions

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w BIOLOGICAL

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 4 mg/kg, q2w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w BIOLOGICAL

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 6 mg/kg, q2w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w BIOLOGICAL

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 8 mg/kg, q2w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3w BIOLOGICAL

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 4mg/kg, q3w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w BIOLOGICAL

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.

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Beijing VDJBio Co., LTD.: lead

Study Sites (3)

Peking Union Medical College Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

West China Hospital of Sichuan Hospital

Chengdu, China

Location

Study Officials

• Jian li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 26, 2022
• Study Start: April 18, 2022
• Primary Completion: November 27, 2022
• Study Completion: December 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)