This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined with Rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Age ≥18 years, male or female.
Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.
Subjects have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Subjects have failed at least one prior thrombopoietin receptor agonist therapy (such as rhTPO, eltrombopag, hetrombopag, etc.) in second-line treatment, as well as rituximab/anti-CD38 monoclonal antibody therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Alternatively, subjects have experienced treatment failure or post-splenectomy relapse following splenectomy.
Subjects with a platelet count of <30×10^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) <30×10^9/L during the screening visit, and no platelet count > 35×10^9/L.
Subjects allergic to CD20 monoclonal antibody or CD38 monoclonal antibody.
Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.
Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.
Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.
Single group
Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody）
DrugFor subjects in this study, rituximab (375mg/m2) was given once (day1) and Daratumumab（Anti-CD38 Monoclonal Antibody） (16mg/kg) was given eight times (day8,15,22,29,36,43,50,57).
Overall response rate at week 12
Overall response rate was defined as either partial response or complete response at week 12. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to \<100×10\^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10\^9/L, with no bleeding.
Response at each visit
Response at each visit was defined as either overall response, partial response, complete response or the proportion of subjects with a platelet counts ≥ 50×10\^9/L and at least twice the baseline level at each visit. Overall response rate was defined as either partial response or complete response. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to \<100×10\^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10\^9/L, with no bleeding.
Platelet counts at each visit
Platelet counts at each visit was defined as the platelet counts at each visit.
Time to the first platelet counts ≥30×10^9/L
Time to the first platelet counts ≥30×10\^9/L was defined as time to first platelet counts ≥30×10\^9/L with at least doubling from baseline
Time to the first platelet counts ≥50×10^9/L
Time to the first platelet counts ≥50×10\^9/L was defined as time to first platelet counts ≥50×10\^9/L with at least doubling from baseline
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