Clinical Trial

HY001N for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if HY001N cell injection safety and tolerability in adult patients with autoimmune hemolytic anemia after failure of 3 or more lines of therapy. It will also learn about the efficacy of HY001N cell injection to treat adult patients with autoimmune hemolytic anemia. The main questions it aims to answer are: Proportion of participants attaining a CR (defined as normalization of hemoglobin not attributed to transfusion effect and the normalization of hemolytic markers) or CRi (defined as normalization of hemoglobin not attributed to transfusion effect without normalization of hemolytic markers) after HY001N infusion? Proportion of participants attaining a PR (defined as hemoglobin ≥ 100 g/L or at least ≥ 20 g/L increase from baseline not attributed to transfusion effect) after HY001N infusion. • What medical problems do participants have when taking HY001N cell injection? Researchers will see if HY001N cell injection works to treat autoimmune hemolytic anemia. Participants will: * Take apheresis, lymphodepletion regimen and HY001N cell injection. * Visit the clinic on schedule.
Trial Details
NCT Number NCT07748533
Lead Sponsor Juventas Cell Therapy Ltd.
Conditions Autoimmune Hemolytic Anemia (AIHA)
Enrollment 9 participants
Start Date 2026-07-02
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-05