Status:
NOT_YET_RECRUITING
A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
Lead Sponsor:
Bing Han
Conditions:
Autoimmune Hemolytic Anemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 approximatel...
Detailed Description
Enatumab (BCMA/CD3 bispecific antibody) is a bispecific T-cell articulation antibody targeting BCMA. Its Fab segment can bind to BCMA of plasma cells, plasma blasts and multiple myeloma cells as well ...
Eligibility Criteria
Inclusion
- 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.
- Hemoglobin (HGB) ≤100g/ and ≥ 60g/L.
- 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.
- 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
- (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.
Key Trial Info
Start Date :
September 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2027
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT07190261
Start Date
September 18 2025
End Date
September 18 2027
Last Update
September 24 2025
Active Locations (1)
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1
Peking union medical college hospital
Beijing, Shuangfuyuan, NO I., China, 100730