A Phase I/II Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment

Inclusion criteria

• ✓. Subjects aged 14-70 years (inclusive), male or female;
• ✓. Subjects who undergone allogeneic hematopoietic stem cell transplantation as indicated for hematological malignant disease, developed with grade II to IV aGvHD and failed standard first-line steroid therapy (that is, SR-aGvHD); 1) Definition of standard first-line steroid /glucocorticoid therapy: 1 mg/kg/day or 2 mg/kg/day of Methylprednisolone, or equivalent doses of steroids; 2) According to Thomas' Hematopoietic Cell Transplantation: Stem Cell Transplantation (5th edition), subjects who meet one of the following criteria are considered to have failed the standard first-line steroid /glucocorticoid therapy:
• ✓. Investigator assessment: Expected survival ≥ 3 months;
• ✓. Clinical manifestations of aGvHD are rash and/or persistent nausea, vomiting, and/or diarrhea and/or cholestasis. For these clinical manifestations, other etiologies such as drug rash, intestinal infection, or hepatotoxicity syndrome have been ruled out;
• ✓. Subjects will be required to receive the investigational product within 3 days of enrollment;
• ✓. Subjects must give informed consent to the study prior to enrollment, with the subject himself/herself, or, the subject himself/herself and his/her legal guardian (only for subjects \<18 years of age), voluntarily signing a written informed consent form.

Exclusion criteria