IMCD
Conditions
Interventions
Intervention Group:Injection VDJ006
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years, regardless of gender; 2. Measurable and symptomatic iMCD confirmed by biopsy or central pathology (iMCD is diagnosed according to the Chinese Expert Consensus on the Diagnosis and Treatment of Castleman Disease (2021 Edition)); 3. The clinical laboratory test values within 4 weeks before treatment meet the following standards: 1) Absolute neutrophil count (ANC) = 1.0 × 109/L 2) Platelet count (Plt) = 75 × 109/L 3) Alanine aminotransferase (ALT) < 2.5 × ULN 4) Total bilirubin (TBIL) < 2.5 × ULN 5) Alkaline phosphatase (ALP) < 2.5 × ULN 6) Serum creatinine (Scr) = 3.0 mg/dL (265 umol/L). 4. ECOG-PS physical status score is 0, 1 or 2; 5. When corticosteroids are used, the dose of prednisone shall not exceed 1 mg/kg/day (or equivalent dose, see Appendix 7), and the dose shall be stable or reduced within 4 weeks before the first administration; 6. Patients of childbearing age (male and female) must agree to take effective contraceptive measures during the trial period and within 3 months after the last drug use. No male is allowed to donate sperm and no female is allowed to donate eggs; 7.Subjects themselves (or their legally recognized representatives) must sign an informed consent form before performing any specific procedure of the study, indicating that they understand the purpose of the study and the procedures to be carried out, and voluntarily participate in the study.
Exclusion criteria
Exclusion criteria: 1. HIV or HHV-8 positive; 2. Skin lesion is the only measurable lesion; 3. Patients with malignant tumors (disease free time1000 IU/ml, HCV, syphilis, active pulmonary tuberculosis); 8. History of allograft transplantation (except corneal transplantation); 9. It is known that there is severe infusion reaction to monoclonal antibody or mouse, chimeric or human protein; 10. Pregnant or lactating women, or those who have pregnancy plans within 3 months after the last medication; 11. Those who have been vaccinated with novel coronavirus vaccine or other live attenuated vaccine within 4 weeks before the first administration or who plan to be vaccinated during the trial period; 12. Those who have participated in other clinical trials within 1 month before the first administration; 13. Paraneoplastic pemphigus or obliterative bronchiolitis; 14. Patients with bleeding history: 1) Intracranial hemorrhage occurred within 6 months before screening; 2) Active bleeding within 2 months before screening. 15. Brain infarction occurred within 6 months before screening (except lacunar cerebral infarction); 16. Any other circumstances that the investigator judges are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
china
Contacts
Public ContactLi Jian
Outcome results
None listed