B Cell Lymphoma
Conditions
Brief summary
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.
Interventions
BIOLOGICALJHL1101
100 mg/10 mL solution in a single-use vial
BIOLOGICALRituximab
100 mg/10 mL solution in a single-use vial
Sponsors
JHL Biotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. CD20-positive B-cell lymphoma. 2. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy 3. 18 years to 75 years 4. Signed an informed consent 5. Adequate organ function, including the following * Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN * Serum creatinine ≤ 1.5 times the ULN 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 7. Chemotherapy: must not have received within 8 weeks of entry onto this study 8. Radiotherapy: must not have received within 4 weeks of entry onto this study 9. Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia 10. Aagreement to practice contraception 11. More than 6 months life expectancy.
Exclusion criteria
1. Received any investigational drug within 28 days prior to study enrollment 2. Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment 3. Received previous immunotherapy 4. Received or plan to receive a live vaccine within 28 days of study enrollment 5. Major surgery within 28 days of study enrollment 6. Received systemic steroid therapy with 28 days of study enrollment 7. Received or plan to receive the hematopoietic cell transplant 8. History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment 9. Known allergic reactions against monoclonal antibody or rituximab. 10. Received rituximab or other anti-CD20 monoclonal antibody 11. Blood concentration of rituximab \> 10 ug/mL during screen visit 12. Human immunodeficiency virus (HIV) positive 13. Hepatitis C virus (HCV) antigen and antibody positive 14. Hepatitis B virus surface antigen (HBsAg) positive 15. Body Mass Index (MBI) ≥ 28 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0~t | 91 days | Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞ | 91 days | AUC from time 0 of the first infusion on Day 1 extrapolated to infinity |
| Cmax | 91 days | Maximum concentration after infusion |
Countries
China
Outcome results
None listed