warm antibody autoimmune hemolytic anemia
Conditions
Interventions
Zuberitamab combined with glucocorticoid group:Zebetuximab 100 mg/d on days 8, 15, 22, and 29 (4 doses in total) in combination with prednisone 1 mg/kg/d (tapering starting from week 4).
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >=18 years; 2. Confirmed diagnosis of autoimmune hemolytic anemia (AIHA) or Evans syndrome meeting the diagnostic criteria for relapsed/refractory disease; 3. Meet the criteria for DAT-negative AIHA, with no other hereditary or acquired hemolytic diseases; 4. Adequate function of major organs: serum ALT and AST =3 months; 7. Able to provide written informed consent, understand and comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1. Prior diagnosis of malignancy-associated autoimmune hemolytic anemia (AIHA); 2. Pregnant or breastfeeding women; 3. Prior history of solid organ or hematopoietic stem cell transplantation; 4. History of thrombosis or organ infarction; 5. Active connective tissue disease; 6. Diagnosis of hereditary hemolytic disease; 7. Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent infection-related signs and symptoms with no improvement despite antibiotic or other targeted therapies); 8. Confirmed active human immunodeficiency virus (HIV) infection, or active hepatitis B or hepatitis C viral infection; 9. Documented prior neurological or psychiatric disorders, including epilepsy or dementia; 10. Concomitant illnesses that, in the Investigator’s judgment, would pose significant safety risks to the patient or interfere with study completion; 11. Concurrent use of any other investigational product, or participation in another clinical trial within 1 month prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Outcomes (including safety, relapse rate, adverse events (AE), and serious adverse events (SAE));Complete Response (CR);Partial Response (PR);Time to Response;Duration of Response; | — |
Countries
China
Contacts
Public ContactTong Hongyan
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed