Active — Not RecruitingPhase 2

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

China25 participantsStarted 2022-04-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

What they're measuring

Number of Participants with Adverse Events(AEs) as Assessed by CTCAE v5.0

Timeframe: 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

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

Trial details

NCT IDNCT05345522

SponsorBeijing VDJBio Co., LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-27

View on ClinicalTrials.gov More Idiopathic Multicentric Castleman's Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

What they're measuring

Number of Participants with Adverse Events(AEs) as Assessed by CTCAE v5.0

Timeframe: 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

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