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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT05345522
• Date of registration: 19/04/2022
• Prospective Registration: No
• Primary sponsor: Beijing VDJBio Co., LTD.
• Public title: A Study of Anti-IL-6R mAb Injection in Patients With iMCD
• Scientific title: A Single-arm, Open-label, Multi-center Phase ?a 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
• Date of first enrolment: April 18, 2022
• Target sample size: 9
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05345522
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Jian li, M.D.
• Affiliation: Peking Union Medical College Hospital

• Name: Xiaoming Gong, Msc

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =18 years old, gender is not limited;

2. 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));

3. 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; Alkaline phosphatase (ALP) <2.5×ULN; Serum creatinine (Scr) = 3.0 mg/dL (265
umol/L).

4. ECOG PS physical status score of 0, 1 or 2 points;

5. 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;

6. 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;

7. The subjects 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:

1. Human immunodeficiency virus (HIV) or human herpesvirus 8 (HHV-8) positive;

2. Skin lesions are the only detectable lesions;

3. 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;

4. 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;

5. 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-a (TNF-a) 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.

6. 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;

7. 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);

8. History of allogeneic transplantation (except corneal transplantation);

9. Those who are known to have severe infusion reactions to monoclonal antibodies or
murine, chimeric or human proteins;

10. Pregnant or lactating women, or those who plan to become pregnant within 3 months
after the last dose;

11. 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;

12. Those who have participated in other clinical trials within 1 month before the first
administration;

13. Patients with paraneoplastic pemphigus or bronchiolitis obliterans;

14. Patients with a history of bleeding,including:

Intracranial hemorrhage within 6 months before screening; Active bleeding within 2
months prior to screening.

15. Patients with cerebral infarction within 6 months before screening (except lacunar
infarction);

16. Any other circumstances judged by the investigator to be inappropriate to participate
in this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Multicentric Castleman's Disease

Intervention(s)

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8mg/kg

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6mg/kg

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg

Primary Outcome(s)

Number of Participants with Adverse Events(AEs) as Assessed by CTCAE v5.0 [Time Frame: Up to 8 weeks]

Grades of all the Adverse Events(AEs) by CTCAE v5.0 [Time Frame: Up to 8 weeks]

Secondary Outcome(s)

Percentage of Participants Who Achieved Overall Response Rate(ORR)for Lymph Nodes [Time Frame: Up to 8 weeks]

Concentration of Anti-Drug Antibody (ADA) [Time Frame: Up to 8 weeks]

Percentage of Participants Who Achieved Overall Response Rate(ORR)for Biochemical Response [Time Frame: Up to 8 weeks]

Concentration of Soluble Interleukin-6 Receptor (sIL-6R) [Time Frame: Within 1 hour before the first dose. 24, 72, 168,336 hours first post-dose.]

Concentration of Interleukin-6 (IL-6) [Time Frame: Within 1 hour before the first dose. 8, 24, 72, 168,336 hours first post-dose.]

Cmax [Time Frame: Up to 8 weeks]

Percentage of Participants Who Achieved Overall Response Rate(ORR)for Symptomatic Response [Time Frame: Up to 8 weeks]

AUC0-t [Time Frame: Up to 8 weeks]

Concentration of Neutralizing Antibody (NAb) [Time Frame: Up to 8 weeks]

Secondary ID(s)

VDJ001-MCD-?a

Source(s) of Monetary Support

Please refer to primary and secondary sponsors