Enatumab for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
enatumab
Anemia+4
+ Anemia, Hemolytic
+ Anemia, Hemolytic, Autoimmune
Treatment Study
Summary
Study start date: September 18, 2025
Actual date on which the first participant was enrolled.This clinical study is focused on testing a new treatment called Enatumab for individuals with relapsed or difficult-to-treat Warm Antibody Autoimmune Hemolytic Anemia (AIHA). AIHA is a condition where the body's immune system mistakenly attacks its own red blood cells, leading to their destruction. Enatumab is designed to target specific proteins on cells involved in this process, potentially reducing the production of harmful autoantibodies. The study aims to see if this treatment can effectively manage the condition by decreasing these damaging antibodies, offering hope for people who have not found success with other treatments. Participants in this study will receive Enatumab, which works by engaging the body's immune cells to target and eliminate abnormal plasma cells responsible for producing autoantibodies. The treatment is given in a way that allows it to specifically bind and activate immune responses against these harmful cells. Researchers will monitor changes in blood indicators like hemoglobin levels and markers of red blood cell destruction to evaluate the treatment's effectiveness. While previous reports have noted some mild side effects such as skin reactions and decreased immune proteins, the safety profile is considered manageable. This study hopes to establish Enatumab as a reliable option for managing AIHA, especially for those with limited options.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Age ≥18 years old, gender not limited. 2. Primary wAIHA with a clear diagnosis. 3. 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. 4. 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. 5. Hemoglobin (HGB) ≤100g/ and ≥ 60g/L. 6. Before treatment, the patient's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times the upper limit of normal (ULN), and the serum creatinine was less than 1.5 times ULN. 7. Voluntarily join this study, sign the informed consent form with good compliance, and be willing to cooperate with regular follow-ups for efficacy evaluation and side effect monitoring. Exclusion Criteria: * (1) Those with impaired functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency. (2) Patients with connective tissue diseases and other secondary AIHA. (3) There is an active infection of hepatitis B virus (HBV), hepatitis C virus (HCV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), human immunodeficiency virus (HIV), or any uncontrolled bacterial, fungal or viral infection. (4) Complicated with malignant tumors or a history of tumors. (5) When screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc. (6) Had received other BCMA-targeted or CART treatments before screening. (7) Pregnant or lactating women. (8) Activity ≥ grade 2 peripheral sensory/motor neuropathy. (9) Had received treatment with other experimental drugs within 30 days (or as required by local regulations) or within 5 half-lives (whichever is longer) prior to the first use of the intervention drug in this study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Peking union medical college hospital
Beijing, ChinaOpen Peking union medical college hospital in Google Maps