SHR0302 and Steroid as First Line Therapy for Chronic GVHD

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• ≥ 18 years old and ≤ 70 years old, male or female;

• Patients receiving allogeneic peripheral blood stem cell transplantation for hematological diseases;

• The primary hematological malignancies are completely relieved and are expected to be stable for at least 3 months;

• Chronic GVHD that was first attacked after transplantation and at least 100 days after transplantation, reached a moderate or severe level by NIH classification;

• There was no previous systemic treatment (including in vitro illumination [ECP]);

• The patient may be receiving other immunosuppressive agents to prevent or treat acute GVHD, but if the subject receives prednisone to prevent or treat acute GVHD, it must be <0.5 mg/kg/d or equivalent dose of other glucocorticoids;

• The chronic GVHD that has started hormone therapy does not exceed 72 hours;

• Karnofsky score > 60 points;

• Patients must be able to understand and are willing to participate in the study and sign an informed consent form.

Exclusion Criteria:

• Can not tolerate prednisone dose 1mg / kg / d or equivalent dose of other glucocorticoids for the treatment of cGVHD;

• Receive any systemic treatment of cGVHD, except for corticosteroids that treat cGVHD within 72 hours prior to the signing of informed consent;

• Patients with GVHD overlap syndrome (NIH criteria);

• Treatment of acute GVHD has received other Jak inhibitors such as ruxolitinib;

• Pregnant or lactating women;

• The patient is judged by the investigator to have complications that may cause other risks;

• The patient is receiving other study medications;

• Patient blood routine: ANC <1.0 × 109 / L or PLT < 50 × 109 / L;

• Non-GVHD-related liver damage: the aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio is more than 3 times normal or the direct bilirubin normal value is more than 3 times;

• Renal dysfunction: endogenous creatinine clearance (Ccr) < 50mL/min or normal serum creatinine 1.5 times or more, regardless of hemodialysis treatment;

• Uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever without symptoms or signs and cannot be ruled out Infected person

• People living with HIV;

• Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy; patients with HBV activation risk refer to patients with hepatitis B surface antigen-positive or core antibody-positive patients who are not treated with anti-HBV;

• The patient's primary malignant disease recurs and the graft is rejected;

• Those who are allergic to known JAK inhibitors.