A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBing Han

About this trial

Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.

Eligibility criteria

Qualifiers

Age ≥18 years old, gender not limited.

Primary wAIHA with a clear diagnosis.

Patients who have relapsed or are refractory after at least second-line treatment (previous treatments include at least two types of glucocorticoids, CD20 monoclonal antibodies or other immunosuppressants). Refractory is defined as failure to achieve partial remission after 6 months of treatment with a stable dose of immunosuppressants.

The infusion of CD20 monoclonal antibody should be at least three months apart. If taking immunosuppressants such as cyclosporine and sirolimus, the medication should be discontinued for at least one month.

Disqualifiers

(1) Those with impaired functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency.

Trial design

Treatments tested in this trial

  • enatumab

Treatment groups

3 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bing Han

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution