A Phase 2 interventional study of Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w and Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w in Idiopathic Multicentric Castleman's Disease, sponsored by Beijing VDJBio Co., LTD.. Active, not recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Beijing VDJBio Co., LTD. · Phase 2, Interventional, and Treatment
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.
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the patient completes four cycles of administration, if no significant safety events are found or the patient has not withdrawn from the trial due to significant safety events and has a significant treatment effect, and if the investigator determines that they may benefit from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.
Beijing VDJBio Co., LTD. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
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.
Patients with a history of bleeding，including:
Intracranial hemorrhage within 6 months before screening; Active bleeding within 2 months prior to screening.
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 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, 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, 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, as the low dose group in Phase II.
Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3w
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, 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, 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, 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, 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.
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.
Time frame: 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.
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 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.
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
ORR is Complete Response (CR) + Partial Response (PR) , assessed according to International Working Group ( IWG ) 1999 criteria.
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
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.
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)
The concentrations of ADA in serum will be tested.
Time frame: 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.
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)
The concentrations of sIL-6R in the serum of each subject are measured.
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)
The concentrations of IL-6 in the serum of each subject are measured.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 2 years in Phase I and 1 year in phase II
Plan to share: No
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Beijing VDJBio Co., LTD.