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
Qualifiers
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
Treatments tested in this trial
- Anti-CD38 antibody Injection
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov