NCT05345522

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Beijing VDJBio Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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the patient completes four cycles of administration, if no significant safety events are found or the patient has not withdrawn from the trial due to significant safety events and has a significant treatment effect, and if the investigator determines that they may benefit from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.

Conditions

• Idiopathic Multicentric Castleman's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w	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.
BIOLOGICAL	Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w	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.
BIOLOGICAL	Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w	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.
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 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	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.

Timeline

• Start date: 2022-04-18
• Primary completion: 2022-11-27
• Completion: 2025-12-31
• First posted: 2022-04-26
• Last updated: 2025-08-08

Locations

3 sites across 1 country: China