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NCT07816341
Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia
Conditions: Autoimmune Hemolytic Anemia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 12
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Location: Red Blood Cell Diseases Center and Regenerative Medicine Center Tianjin Tianjin Municipality
Summary
This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. The main purpose of the study is to evaluate the safety and tolerability of F182112 and to identify an appropriate dose for further clinical development.
Eligibility Criteria
Inclusion Criteria:
* Age 18-75 years.
* Diagnosis of AIHA according to established Chinese or international criteria, including warm AIHA, mixed AIHA, cold agglutinin disease, or Evans syndrome.
* Refractory to multiple lines of therapy, meeting all of the following: HGB \
Source: ClinicalTrials.gov (NCT07816341). StuddyBuddy aggregates publicly available trial information.