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NCT05345522
A Study of Anti-IL-6R mAb Injection in Patients With iMCD
Phase 2 trial testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w in Idiopathic Multicentric Castleman's Disease in 25 participants. Participants enrolled and being followed up; not accepting new ones.
27 November 2022
Quick facts
| Lead sponsor | Beijing VDJBio Co., LTD. |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 18 April 2022 |
| Primary completion | 27 November 2022 |
| Estimated completion | 31 December 2025 |
| Sites | 3 locations across China |
Drugs / interventions 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
Conditions studied
- Idiopathic Multicentric Castleman's Disease — all drugs for Idiopathic Multicentric Castleman's Disease →
Sponsor
Beijing VDJBio Co., LTD. — full company profile →
Who can join
18 and older, any sex, with Idiopathic Multicentric Castleman's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05345522
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Idiopathic Multicentric Castleman's Disease
Currently open trials in the same condition.
- NCT07085039 — Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease · Phase 2 · recruiting
Other Beijing VDJBio Co., LTD. trials
Trials by the same sponsor.
- NCT06726096 — Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis · Phase 3 · enrolling by invitation
- NCT05957107 — Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis · Phase 2 · completed
- NCT05256719 — Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects · Phase 1 · recruiting
- NCT05232396 — Clinical Study of Single Dose IL-6R mAb Injection in RA Patients · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05345522 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing VDJBio Co., LTD.
- Last refreshed: 8 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05345522.
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