Status:
ACTIVE_NOT_RECRUITING
A Study of Anti-IL-6R mAb Injection in Patients With iMCD
Lead Sponsor:
Beijing VDJBio Co., LTD.
Conditions:
Idiopathic Multicentric Castleman's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- Intracranial hemorrhage within 6 months before screening; Active bleeding within 2 months prior to screening.
- Patients with cerebral infarction within 6 months before screening (except lacunar infarction);
- Any other circumstances judged by the investigator to be inappropriate to participate in this study.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05345522
Start Date
April 18 2022
End Date
December 31 2025
Last Update
August 8 2025
Active Locations (3)
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1
Peking Union Medical College Hospital
Beijing, China
2
Peking University First Hospital
Beijing, China
3
West China Hospital of Sichuan Hospital
Chengdu, China