Treatment of Evans Syndrome with Anti-CD38 Antibody

A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Evans Syndrome

This study is testing a new antibody treatment for adults with Evans syndrome who haven't had enough success with other therapies to see if it can help improve their condition.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: rituximab, Daratumumab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06014775 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of Anti-CD38 antibody in adults with Evans syndrome who have not responded adequately to previous treatments. It is a single-center, open-label study that focuses on patients who have experienced relapse after first-line therapy and at least one second-line therapy. The study aims to evaluate the biological activity of the antibody in targeting pathogenic plasma cells that contribute to the disease. Participants will receive injections of the Anti-CD38 antibody and will be monitored for clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of primary Evans syndrome who have not responded to previous treatments.

Not a fit: Patients who have not been diagnosed with Evans syndrome or those who have not undergone prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with refractory Evans syndrome.

How similar studies have performed: While the use of Anti-CD38 antibodies has shown promise in other autoimmune conditions, this specific application in Evans syndrome is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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;
* If receiving emergency care for ES, treatment should be stopped \>2 weeks before first dose.
* DAT positive (IgG+, with or without C3+).
* The patient need to be in the state of active hemolysis.
* With normal hepatic and renal functions.
* ECOG performance status ≤2.
* Cardiac function: New York Heart Association functional class ≤2.
* For patients receiving maintenance treatment, corticosteroids must have a stable dose at least 2 weeks before the first administration, TPO receptor agonists and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of anti-CD20 antibody treatment was\>6 months.The end of alkylating agent treatment was\>2 months.
* Understand the study procedures and voluntarily sign the informed consent form in person.

Exclusion Criteria:

* 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;
* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;
* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;
* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;
* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;
* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;
* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;
* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);
* Patients with septicemia or other irregular severe bleeding;
* Patients taking antiplatelet drugs at the same time;
* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.

Where this trial is running

Tianjin, Tianjin Municipality

• Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lei Zhang, M.D — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Ting Sun, M.D

Conditions Evan Syndrome; Treatment