Anti-CD38 Antibody Treating Evans Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
A single-center, open-label, off-label use investigator-initiated clinical study with safety run-in to explore the clinical activity and safety of Anti-CD38 Antibody in adult ES patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including immunosuppressive agents, Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged ≥18 years.
Prior to enrollment, a clinical diagnosis of primary Evans syndrome was made.
Platelet count < 30×10^9/L or Hb < 100g/L or symptomatic anemia within 48 hours before the first administration of study drug;
Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy or those who cannot chose other second-line therapy;
Disqualifiers
Secondary Evans syndrome. Received any treatment of anti-CD38 antibody drug
Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;
HIV positive;
Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;
Trial design
Design model
Single group
Treatments tested in this trial
Anti-CD38 antibody Injection
Drugintravenous Anti-CD38 antibody administration This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks. The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment. The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Intervention（Anti-CD38 antibody）Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of overall efficacy response after Anti-CD38 antibody treatment within 8 weeks
Overall response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease at least once within 8 weeks after the first dose.
Time frame
8 weeks2
Safety of Anti-CD38 antibody treatment
Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD38 antibody treatment
Time frame
24 weeksSecondary outcomes
1
Evaluation of stable sustained response after Anti-CD38 antibody treatment at week 8
Stable sustained response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease in 3 consecutive accessible assessments at least 7 days apart 8 weeks after the first dose.
Time frame
8 weeks2
Number of Participants With ES Response to Anti-CD38 antibody treatment
Complete response (CR) is complete resolution in all autoimmune cytopenias (neutropenia, anemia thrombocytopenia) maintained for more than two months, combined with an ability to wean off corticosteroids and/or other immunosuppressive medication. Partial response (PR) is improvement in any cytopenias by at least one grade, lasting more than two months, without worsening any other cytopenias or stable disease with the ability to wean corticosteroids and/or immunosuppressive medications by at least 50%. No response (NR) is no change in cytopenias with treatment, and the inability to wean corticosteroids or other immunosuppressive medications. Progressive disease (PD) refers to obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug.
Time frame
24 weeks3
Measurements of platelet count at each visit time point
Platelet count at each visit time point
Time frame
24 weeks4
Measurements of Hb value at each visit time point
Hb value at each visit time point
Time frame
24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov