Heyuan Bio Announces Phase I Clinical Trial Initiation of Naji-Olunse Injection for Autoimmune Hemolytic Anemia

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that the Phase I, multi-center, open-label, single-arm clinical trial for the safety and tolerability of Najiolumab Injection, developed by Guangdong Juventas Biopharmaceutical Co., Ltd. / Juventas (Tianjin) Biotechnology Co., Ltd., for treating autoimmune hemolytic anemia patients who have failed at least three prior treatment lines, has been initiated. The clinical trial registration number is CTR20253663, with the initial information disclosure date on September 9, 2025.

The drug formulation is an injection, with a specification of 20mL/bag. The dosage is divided into different dose groups: Group A - 1 dose is 0.25×10^6 CAR-T viable cells/kg body weight, Group A (starting dose) is 0.5×10^6 CAR-T viable cells/kg body weight, Group B is 1.0×10^6 CAR-T viable cells/kg body weight, and Group C is 1.5×10^6 CAR-T viable cells/kg body weight. The dosing schedule is within 1 hour after revival. The primary objective of this trial is to evaluate the safety and tolerability of Naciorlen Cell Injection in treating autoimmune hemolytic anemia that has failed at least three prior lines of therapy and to determine the recommended Phase II dose; secondary objectives include assessing its efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity.

Najiolun Injection is a biological product, indicated for autoimmune hemolytic anemia. This disease occurs due to immune dysfunction that leads to the production of autoantibodies, causing accelerated destruction of red blood cells. Symptoms include anemia, jaundice, and splenomegaly, with diagnosis relying on laboratory tests such as the antiglobulin test.

The primary endpoint indicators of this trial include dose-limiting toxicity (DLT), recommended Phase II dose (RP2D), and safety assessment; secondary endpoint indicators include overall response rate (ORR), changes in laboratory parameters from baseline, time to response (TTR), recurrence-free remission time, FACIT fatigue score, and SF-36 score.

Currently, the trial status is ongoing (not yet recruiting).

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Editor: Xiaolang Express